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1

Anexa I
Lista cu denumirile comerciale, formele farmaceutice, concentraiile, cile
de administrare ale medicamentelor, deintorii autorizaiei de punere pe
pia n statele membre


2

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria Pfizer Corporation Austria
Ges.m.b.H
Floridsdorfer Hauptstrae 1,
1210 Vienna
Austria
Diclofenac sodic
Misoprostol
Arthrotec forte -
Manteltabletten
75mg
0.2mg
Drajeu Administrare oral
Austria Pfizer Corporation Austria
Ges.m.b.H
Floridsdorfer Hauptstrae 1,
1210 Vienna
Austria
Diclofenac sodic
Misoprostol
Arthrotec -
Manteltabletten
50mg
0,2mg
Drajeu Administrare oral
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Dedolor akut 75 mg
Kapseln
75mg Capsul
gastrorezistent
Administrare oral
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Dedolor DRS 100 mg
Kapseln
100mg Capsul Administrare oral
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Deflamat DRS 75
mg Kapseln
75mg Capsul Administrare oral
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Deflamat 75 mg -
Ampullen
75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
3

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Deflamat 50 mg
Kapseln
50mg Capsul Administrare oral
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Deflamat 100 mg
Suppositorien
100mg Supozitor Administrare
rectal
Austria Astellas Pharma GmbH
Linzer Strae 221/E02
1140 Vienna
Austria
Diclofenac sodic Deflamat retard 100
mg Kapseln
100mg Capsul Administrare oral
Austria Hexal Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic DiclacHexal 50 mg -
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria Hexal Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic DiclacHexal rapid 50
mg - lsbare
Tabletten
50mg Comprimat
pentru soluie
oral
Administrare oral
Austria Hexal Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic DiclacHexal retard
150 mg - Tabletten
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Austria Hexal Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic DiclacHexal retard
75 mg - Tabletten
75mg Comprimat cu
eliberare
prelungit
Administrare oral
4

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene 75 mg
Ampullen
75mg/2ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene 25 mg
Filmtabletten
25mg Comprimat filmat Administrare oral
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene 50 mg
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
5

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene retard 100
mg - Kapseln
100mg Capsul Administrare oral
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac sodic Diclobene uno 150
mg - Retardtabletten
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Austria 1A Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Diclofenac akut 1A
Pharma 50 mg -
lsbare Tabletten
50mg Comprimat
pentru soluie
oral
Administrare oral
Austria Genericon Pharma
Gesellschaft m.b.H.
Hafnerstrae 211
8054 Graz
Austria
Diclofenac sodic Diclofenac Genericon
75 mg - Ampullen
75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Austria Genericon Pharma
Gesellschaft m.b.H.
Hafnerstrae 211
8054 Graz
Austria
Diclofenac sodic Diclofenac
"Genericon" 50 mg -
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria Genericon Pharma
Gesellschaft m.b.H.
Hafnerstrae 211
8054 Graz
Austria
Diclofenac sodic Diclofenac Genericon
retard 100 mg
Filmtabletten
100mg Comprimat filmat Administrare oral
6

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria S.MED Handels GmbH
Zachgasse 1
1220 Vienna
Austria
Diclofenac sodic DICLOFENAC
"S.Med" 25 mg-
Filmtabletten
25mg Comprimat filmat Administrare oral
Austria S.MED Handels GmbH
Zachgasse 1
1220 Vienna
Austria
Diclofenac sodic DICLOFENAC
"S.Med" 50 mg -
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria S.MED Handels GmbH
Zachgasse 1
1220 Vienna
Austria
Diclofenac sodic Diclofenac S.Med
75 mg/3 ml -
Ampullen
75mg/3ml Soluie injectabil Administrare
intramuscular
Austria S.MED Handels GmbH
Zachgasse 1
1220 Vienna
Austria
Diclofenac sodic DICLOFENAC
"S.Med" retard 100
mg - Tabletten
100mg Comprimat Administrare oral
Austria S.MED Handels GmbH
Zachgasse 1
1220 Vienna
Austria
Diclofenac sodic DICLOFENAC
"S.Med" retard 75
mg - Tabletten
75mg Comprimat Administrare oral
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclofenac G.L. 50
mg - Filmtabletten
50mg Comprimat filmat Administrare oral
Austria 1A Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Diclofenac 1A
Pharma retard 150
mg - Tabletten
150mg Comprimat cu
eliberare
prelungit
Administrare oral
7

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria 1A Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Diclofenac 1A
Pharma retard 75
mg - Tabletten
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclofenac G.L.
retard 100 mg -
Filmtabletten
100mg Comprimat filmat Administrare oral
Austria Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclofenac Sandoz
75 mg Ampullen
75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Austria Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclofenac Sandoz
50 mg
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclofenac Sandoz
150 mg -
Retardtabletten
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Austria Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclofenac Sandoz
75 mg -
Retardtabletten
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Austria Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclofenac "Sandoz"
retard 100 mg
Filmtabletten
100mg Comprimat filmat Administrare oral
8

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria Lannacher Heilmittel
Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria
Diclofenac sodic Diclo-B Lannacher-
Kapseln
50mg Capsul Administrare oral
Austria Lannacher Heilmittel
Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria
Diclofenac sodic Diclo-B G.L. 50mg Capsul Administrare oral
Austria STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Diclofenac sodic Diclostad Ampullen 75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Austria STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Diclofenac sodic Diclostad 50 mg
Filmtabletten
50mg Comprimat filmat Administrare oral
Austria STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Diclofenac sodic Diclostad retard 100
mg Filmtabletten
100mg Comprimat filmat Administrare oral
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclovit-Kapseln 50mg Capsul Administrare oral
9

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic Dolpasse 75 mg
Infusionslsung
75mg/250ml Soluie
perfuzabil
Administrare
intravenoas
Austria Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic Dolpasse retard 100
mg - Filmtabletten
100mg Comprimat filmat Administrare oral
Austria Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic
Orfenadrin citrat
Neodolpasse
Infusionslsung
75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
intravenoas
Austria MERCK GesmbH
Zimbagasse 5
1147 Vienna
Austria
Diclofenac sodic Neurofenac -
Kapseln
50mg Capsul Administrare oral
Austria Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac sodic Tratul retard 100 mg
- Filmtabletten
100mg Comprimat filmat Administrare oral
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 25 mg -
Filmtabletten
25mg Comprimat filmat Administrare oral
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 50 mg -
Filmtabletten
50mg Comprimat filmat Administrare oral
10

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 75mg/3ml -
Injektionslsung
75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 25 mg -
Zpfchen
25mg Supozitor Administrare
rectal
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 100 mg -
Zpfchen fr
Erwachsene
100mg Supozitor Administrare
rectal
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren 50 mg -
Zpfchen fr
Erwachsene
50mg Supozitor Administrare
rectal
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac sodic Voltaren retard 100
mg - Filmtabletten
100mg Comprimat filmat Administrare oral
Austria Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac Tratul 50 mg -
Kapseln
50mg Capsul moale
gastrorezistent
Administrare oral
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac Voltaren dispers -
lsliche Tabletten
46,5mg Comprimat
pentru soluie
oral
Administrare oral
11

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Austria ratiopharm Arzneimittel
VertriebsGmbH
Albert-Schweitzer-Gasse 3
1140 Vienna
Austria
Diclofenac potasic Diclobene rapid 50
mg Filmtabletten
50mg Comprimat filmat Administrare oral
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac potasic Voltaren 50 mg
Pulver zur
Herstellung einer
Lsung zum
Einnehmen
50mg Pulbere pentru
soluie oral
Administrare oral
Austria Novartis Pharma GmbH
Stella-Klein-Lw-Weg 17
1020 Vienna
Austria
Diclofenac potasic Voltaren rapid 50
mg - Dragees
50mg Drajeu Administrare oral
Belgia Continental Pharma
Rijksweg, 12
B-2870 Puurs
Belgium
Diclofenac sodic
Misoprostol
ARTHROTEC 50 50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
Belgia Continental Pharma
Rijksweg, 12
B-2870 Puurs
Belgium
Diclofenac sodic
Misoprostol
ARTHROTEC 75 75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac potasic CATAFLAM 50 MG 50mg Drajeu Administrare oral
12

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac potasic CATAFLAM 50 MG 50mg Pulbere pentru
soluie oral
Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac CATAFLAM
DISPERSIBLE
46,5mg Comprimat
pentru dispersie
oral
Administrare oral
Belgia APOTEX NV
Av. du Bourg. Etienne
Demunter 5, box 8
1090 Jette
Belgium
Diclofenac sodic DICLOFENAC
APOTEX 100 MG
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia APOTEX NV
Av. du Bourg. Etienne
Demunter 5, box 8
1090 Jette
Belgium
Diclofenac sodic DICLOFENAC
APOTEX 75 MG
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG 100
MG
100mg Supozitor Administrare
rectal
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG
25MG
25mg Drajeu Administrare oral
13

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG 50
MG
50mg Drajeu Administrare oral
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG 75
MG
75mg/3ml Soluie injectabil Administrare
intramuscular
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG
RETARD 100 MG
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic DICLOFENAC EG
RETARD 75 MG
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia Mylan bvba
Rozendal Businesspark
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Diclofenac sodic DICLOFENAC
RETARD MYLAN
100MG
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia Mylan bvba
Rozendal Businesspark
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Diclofenac sodic DICLOFENAC
RETARD MYLAN
75MG
75mg Comprimat cu
eliberare
prelungit
Administrare oral
14

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia SANDOZ N.V.
Telecom Gardens
Medialaan 40
1800 Vilvoorde
Belgium
Diclofenac sodic DICLOFENAC
SANDOZ 50 MG
50mg Comprimat
gastrorezistent
Administrare oral
Belgia SANDOZ N.V.
Telecom Gardens
Medialaan 40
1800 Vilvoorde
Belgium
Diclofenac sodic DICLOFENAC
SANDOZ 75 MG
75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Belgia SANDOZ N.V.
Telecom Gardens
Medialaan 40
1800 Vilvoorde
Belgium
Diclofenac sodic DICLOFENAC
SANDOZ RETARD
100 MG
100mg Comprimat cu
eliberare
modificat
Administrare oral
Belgia SANDOZ N.V.
Telecom Gardens
Medialaan 40
1800 Vilvoorde
Belgium
Diclofenac sodic DICLOFENAC
SANDOZ RETARD 75
MG
75mg Comprimat cu
eliberare
modificat
Administrare oral
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac sodic DICLOFENAC TEVA
100
100mg Supozitor Administrare
rectal
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac sodic DICLOFENAC TEVA
100 MG RETARD
100mg Comprimat cu
eliberare
prelungit
Administrare oral
15

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac sodic DICLOFENAC TEVA
50 MG
50mg Comprimat
gastrorezistent
Administrare oral
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac sodic DICLOFENAC TEVA
75 MG / 3 ML
75mg/3ml Soluie injectabil Administrare
intramuscular
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac sodic DICLOFENAC TEVA
75 MG RETARD
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia Teva Pharma Belgium N.V.
Laarstraat 16
2610 Wilrijk
Belgium
Diclofenac potasic DICLOFENAC-K-
TEVA 50 MG COMPR
50mg Comprimat filmat Administrare oral
Belgia RATIOPHARM BELGIUM S.A.
Rue Saint-Lambert 141
1200 Woluw-saint-lambert
Belgium
Diclofenac sodic DICLOFENAC-
RATIOPHARM 50 MG
GASTRO-
50mg Comprimat
gastrorezistent
Administrare oral
Belgia LABORATORIA QUALIPHAR
N.V/S.A
Rijksweg 9
2880 Bornem
Belgium
Diclofenac sodic DICLOFENACUM
NATRI QUALIPHAR
50 MG
50mg Comprimat
gastrorezistent
Administrare oral
Belgia SOCOBOM N.V.
Louizalaan 149 box 24
1050 Ixelles
Belgium
Diclofenac sodic FLAMPHAR 50 MG 50mg Comprimat Administrare oral
16

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia Daiichi Sankyo Belgium SA
Rue Fond Jean Pques 5
B-1348 Louvain-la-Neuve
Belgium
Diclofenac sodic MOTIFENE 75MG 75mg Capsul cu
eliberare
modificat
Administrare oral
Belgia SOCOBOM N.V.
Louizalaan 149 box 24
1050 Ixelles
Belgium
Diclofenac sodic POLYFLAM 75 MG 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Belgia SOCOBOM N.V.
Louizalaan 149 box 24
1050 Ixelles
Belgium
Diclofenac sodic POLYFLAM EX
RUFIMAX EX
ALGIRHUMA 50 MG
50mg Drajeu Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN 100 100mg Supozitor Administrare
rectal
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN 25 25mg Comprimat
gastrorezistent
Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN 50 50mg Comprimat
gastrorezistent
Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN 75 MG/3
ML
75mg/3ml Soluie injectabil Administrare
intramuscular
17

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN RETARD
100
100mg Comprimat Administrare oral
Belgia NOVARTIS PHARMA N.V.
Medialaan, 40, box 1
1800 Vilvoorde
Belgium
Diclofenac sodic VOLTAREN RETARD
75 MG
75mg Comprimat Administrare oral
Belgia Novartis Consumer Health
S.A.
Medialaan, 40
B-1800 Vilvoorde
Belgium
Diclofenac potasic VOLTATABS 12,5
MG(EX:ZYMAMED)
12,5mg Drajeu Administrare oral
Bulgaria Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral 50mg Comprimat
gastrorezistent
Administrare oral
Bulgaria Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Bulgaria PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac sodic Diclofenac Duo 75mg Capsul cu
eliberare
prelungit
Administrare oral
18

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Bulgaria Tchaikapharma Highquality
Medicines
1 G. M. Dimitrov Blvd.
Sofia 1172
Bulgaria
Diclofenac sodic Diclofenac-
Tchaikapharma
50mg Comprimat
gastrorezistent
Administrare oral
Bulgaria Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Bulgaria Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 75mg Comprimat cu
eliberare
modificat
Administrare oral
Bulgaria Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 150mg Comprimat cu
eliberare
modificat
Administrare oral
Bulgaria Sopharma Pharmaceuticals
5 Lachezar Stanchev Str.
Sofia 1220
Bulgaria
Diclofenac sodic Feloran 100mg Supozitor Administrare
rectal
Bulgaria Actavis EAD
29 Atanas Dukov Str.
Sofia 1407
Bulgaria
Diclofenac sodic Feloran Actavis 100mg Comprimat cu
eliberare
prelungit
Administrare oral
19

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Bulgaria Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen SR 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Bulgaria Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen DUO 75mg Capsul cu
eliberare
modificat
Administrare oral
Bulgaria Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen 75mg/3ml Soluie injectabil Administrare
intramuscular
Bulgaria Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen 50mg Comprimat
gastrorezistent
Administrare oral
Bulgaria Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic
Orfenadrin citrat
Neodolpasse 75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
intravenoas
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
20

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac potasic Voltfast 50mg Pulbere pentru
soluie oral
Administrare oral
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Bulgaria Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Bulgaria Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Dolo 12,5mg Capsul moale Administrare oral
21

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Bulgaria Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Dolo 12,5mg Comprimat filmat Administrare oral
Bulgaria Sopharma Pharmaceuticals
5 Lachezar Stanchev Str.
Sofia 1220
Bulgaria
Diclofenac sodic Feloran 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL INJECTION
75MG/3ML
75mg/3ml Soluie injectabil Administrare
intramuscular
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL
SUPPOSITORY
100MG
100mg Supozitor Administrare
rectal
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL
SUPPOSITORY 50MG
50mg Supozitor Administrare
rectal
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL GASTRO-
RESISTANT TABLET
25MG
25mg Comprimat Administrare oral
22

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL GASTRO-
RESISTANT TABLET
50MG
50mg Comprimat Administrare oral
Cipru Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ARESTON TABLET
50MG
50mg Comprimat Administrare oral
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac potasic CATAFLAM ORAL
DROPS 1.5%
15mg/ml Picturi orale,
soluie
Administrare oral
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac potasic CATAFLAM COATED
TABLET 50MG
50mg Comprimat Administrare oral
Cipru P.T.Hadjigeorgiou CO ltd,
P.O.Box 53158
3301 Lemesos
Cyprus
Diclofenac sodic DICLAC INJECTION
75MG/3ML
75mg/3ml Soluie injectabil Administrare
intramuscular
Cipru Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic DICLAC 50 HEXAL
GASTRO-RESISTANT
TABLET 50MG
50mg Comprimat Administrare oral
23

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Cipru Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic DICLAC 75 ID
HEXAL SUSTAINED
RELEASE TABLET
75MG
75mg Comprimat Administrare oral
Cipru Medlink Pharmaceuticals ltd
30 Armenias Str.
P.O.Box 26576
Strovolos
Cyprus
Diclofenac sodic DIFENE DUAL
CAPSULE 100MG
100mg Capsul Administrare oral
Cipru Medlink Pharmaceuticals ltd
30 Armenias Str.
P.O.Box 26576
Strovolos
Cyprus
Diclofenac sodic DIFENE DUAL
CAPSULE 75MG
75mg Capsul Administrare oral
Cipru Interpak ltd
Aharnon st
Industrial Estate
P.O. Box 51166
3502 Lemesos
Cyprus
Diclofenac sodic NERITAN GASTRO
RESISTANT TABLET
50MG
50mg Comprimat Administrare oral
Cipru Interpak ltd
Aharnon st
Industrial Estate
P.O. Box 51166
3502 Lemesos
Cyprus
Diclofenac sodic NERITAN GASTRO
RESISTANT TABLET
25MG
25mg Comprimat Administrare oral
24

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Cipru Remedica ltd
Aharnon str.
P.O. Box 51706
Lemesos
Cyprus
Diclofenac sodic REMETHAN
SUPPOSITORY
100MG
100mg Supozitor Administrare
rectal
Cipru Remedica ltd
Aharnon str.
P.O. Box 51706
Lemesos
Cyprus
Diclofenac sodic REMETHAN
SUSTAINED
RELEASE TABLET
100MG
100mg Comprimat Administrare oral
Cipru Remedica ltd
Aharnon str.
P.O. Box 51706
Lemesos
Cyprus
Diclofenac sodic REMETHAN GASTRO
RESISTANT TABLET
25MG
25mg Comprimat Administrare oral
Cipru Remedica ltd
Aharnon str.
P.O. Box 51706
Lemesos
Cyprus
Diclofenac sodic REMETHAN GASTRO
RESISTANT TABLET
50MG
50mg Comprimat Administrare oral
Cipru Codal Synto ltd
33 Theklas Lysioti str.
P.O. Box 51785
Lemesos
Cyprus
Diclofenac sodic TAKS INJECTION
75MG/3ML
75mg/3ml Soluie injectabil Administrare
intramuscular
25

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Cipru Codal Synto ltd
33 Theklas Lysioti str.
P.O. Box 51785
Lemesos
Cyprus
Diclofenac sodic TAKS GASTRO
RESISTANT TABLET
50MG
50mg Comprimat Administrare oral
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN
INJECTION
75MG/3ML
75mg/3ml Soluie injectabil Administrare
intramuscular
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN
SUPPOSITORY
100MG
100mg Supozitor Administrare
rectal
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN
SUPPOSITORY 50MG
50mg Supozitor Administrare
rectal
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN GASTRO
RESISTANT TABLET
50MG
50mg Comprimat Administrare oral
26

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN D
DISPERSIBLE
TABLET 50MG
50mg Comprimat Administrare oral
Cipru Novartis Hellas S.A.C.I.
12th km
National Road No1
Metamorfosi Attiki
Athens
Greece
Diclofenac sodic VOLTAREN DOLO
FILM COATED
TABLET 12.5MG
12,5mg Comprimat Administrare oral
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN FOR
CHILDREN
SUPPOSITORY
12.5MG
12,5mg Supozitor Administrare
rectal
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN RETARD
SUSTAINED
RELEASE TABLET
100MG
100mg Comprimat Administrare oral
Cipru Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic VOLTAREN SR
SUSTAINED
RELEASE TABLET
75MG
75mg Comprimat Administrare oral
27

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Republica Ceh Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic ALMIRAL 50 50mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic APO-DICLO SR 100 100mg Comprimat cu
eliberare
modificat
Administrare oral
Republica Ceh Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic APO-DICLO 25 MG 25mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic APO-DICLO 50 MG 50mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic DICLOFENAC AL
RETARD
100mg Comprimat cu
eliberare
prelungit
Administrare oral
28

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic DICLOFENAC AL 25 25mg Comprimat filmat Administrare oral
Republica Ceh ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic DICLOFENAC AL 50 50mg Comprimat filmat Administrare oral
Republica Ceh PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac sodic DICLOFENAC DUO
PHARMASWISS 75
MG
75mg Capsul cu
eliberare
modificat
Administrare oral
Republica Ceh Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 25mg/ml Soluie injectabil Administrare
intramuscular
Republica Ceh Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM RETARD 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Republica Ceh Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 100 100mg Supozitor Administrare
rectal
29

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 50 50mg Supozitor Administrare
rectal
Republica Ceh Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 50 50mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic DICUNO 25 MG
POTAHOVAN
TABLETY
25mg Comprimat filmat Administrare oral
Republica Ceh Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic DICUNO 50 MG
POTAHOVAN
TABLETY
50mg Comprimat filmat Administrare oral
Republica Ceh Zentiva, k.s.
U kabelovny 130
102 37 Praha 10 - Doln
Mcholupy
Czech Republic
Diclofenac sodic DOLMINA INJ 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Republica Ceh Zentiva, k.s.
U kabelovny 130
102 37 Praha 10 - Doln
Mcholupy
Czech Republic
Diclofenac sodic DOLMINA 100 SR 100mg Comprimat cu
eliberare
prelungit
Administrare oral
30

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Zentiva, k.s.
U kabelovny 130
102 37 Praha 10 - Doln
Mcholupy
Czech Republic
Diclofenac sodic DOLMINA 50 50mg Comprimat filmat Administrare oral
Republica Ceh IBSA Slovakia s.r.o.
Mytna 42
811 05 Bratislava
Slovak Republic
Diclofenac
epolamine
FLECTOR EP RAPID
50 MG
50mg Granule pentru
soluie oral
Administrare oral
Republica Ceh Winthrop Arzneimittel GmbH
Industriestrasse 26
Mlheim-Krlich
Germany
Diclofenac sodic MONOFLAM 100 MG 100mg Supozitor Administrare
rectal
Republica Ceh Winthrop Arzneimittel GmbH
Industriestrasse 26
Mlheim-Krlich
Germany
Diclofenac sodic MONOFLAM 50 MG 50mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac sodic MYOGIT 25 25mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac sodic MYOGIT 50 50mg Comprimat
gastrorezistent
Administrare oral
31

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic NAKLOFEN DUO
TOBOLKY
75mg Capsul cu
eliberare
modificat
Administrare oral
Republica Ceh Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic
Orfenadrin citrat
Neodolpasse 75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
intravenoas
Republica Ceh Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic OLFEN-100 SR 100mg Capsul cu
eliberare
prelungit
Administrare oral
Republica Ceh Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic OLFEN-50 50mg Comprimat filmat Administrare oral
32

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic OLFEN-75 37.5mg/ml Soluie injectabil Administrare
intramuscular
Republica Ceh ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic UNO 150mg Comprimat cu
eliberare
prelungit
Administrare oral
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 100 MG 100mg Supozitor Administrare
rectal
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 100 RETARD 100mg Comprimat cu
eliberare
modificat
Administrare oral
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 25 MG 25mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 50 MG 50mg Comprimat
gastrorezistent
Administrare oral
33

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 75 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Republica Ceh Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac sodic VERAL 75 RETARD 75mg Comprimat cu
eliberare
modificat
Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac sodic VOLTAREN 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac sodic VOLTAREN RETARD 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac sodic VOLTAREN 50 50mg Comprimat
gastrorezistent
Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac potasic VOLTAREN RAPID 50
MG TABLETY
50mg Drajeu Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac potasic VOLTAREN ACTIGO 12,5mg Comprimat filmat Administrare oral
34

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac potasic VOLTAREN ACTIGO
EXTRA
25mg Drajeu Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac potasic VOLTAREN RAPID
12,5 MG
12,5mg Capsul moale Administrare oral
Republica Ceh Novartis s.r.o.
Na Pankrci 1724/129
140 00 Praha 4 - Nusle
Czech Republic
Diclofenac potasic VOLTAREN RAPID 25
MG
25mg Capsul moale Administrare oral
Danemarca PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev
Denmark
Diclofenac Diclodan 50mg Supozitor Administrare
rectal
Danemarca PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev
Denmark
Diclofenac Diclodan 100mg Supozitor Administrare
rectal
Danemarca Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kbenahvn S
Denmark
Diclofenac Diclon 100mg Supozitor Administrare
rectal
Danemarca Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kbenahvn S
Denmark
Diclofenac Diclon Rapid 50mg Comprimat filmat Administrare oral
35

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Sandoz A/S
Edvard Thomsens Vej 14
DK-2300 Kbenahvn S
Denmark
Diclofenac Diclon Rapid 25mg Comprimat filmat Administrare oral
Danemarca Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac Diklofenak "Mylan" 50mg Comprimat
gastrorezistent
Administrare oral
Danemarca Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac Diklofenak "Orifarm" 25mg Comprimat
gastrorezistent
Administrare oral
Danemarca Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac Diklofenak "Orifarm" 50mg Comprimat
gastrorezistent
Administrare oral
Danemarca Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac Modifenac 75mg Capsul cu
eliberare
modificat
Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
36

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren 100mg Supozitor Administrare
rectal
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren 25mg/ml Soluie injectabil Administrare
intramuscular
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren 50mg Supozitor Administrare
rectal
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Dolo 12,5mg Comprimat filmat Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Dolo 12,5mg Capsul moale Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Dolo 12,5mg Comprimat Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Rapid 50mg Comprimat Administrare oral
37

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Danemarca Novartis Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhavn
Denmark
Diclofenac Voltaren Retard 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Danemarca BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac Diclofenac "BMM
Pharma"
50mg Comprimat
gastrorezistent
Administrare oral
Danemarca BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac Diclofenac "BMM
Pharma"
25mg Comprimat
gastrorezistent
Administrare oral
Danemarca Actavis Nordic A/S
rnegrdsvej 16
DK-2820 Gentofte
Denmark
Diclofenac Diclofenac Rapid
"Actavis"
50mg Comprimat filmat Administrare oral
Danemarca Actavis Nordic A/S
rnegrdsvej 16
DK-2820 Gentofte
Denmark
Diclofenac Diclofenac Rapid
"Actavis"
25mg Comprimat filmat Administrare oral
Danemarca Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac Diclofenac Rapid
"Orifarm"
50mg Comprimat filmat Administrare oral
38

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac Diclofenac Rapid
"Orifarm"
25mg Comprimat filmat Administrare oral
Danemarca Teva Denmark A/S
Parallelvej 10-12
DK-2800 Kongens Lyngby
Denmark
Diclofenac Diclofenac Rapid
"Teva"
50mg Comprimat filmat Administrare oral
Danemarca Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac Diclon 50mg Comprimat
gastrorezistent
Administrare oral
Danemarca Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac Diclon 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Danemarca Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac Diclon 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Danemarca Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac Diclon 25mg Comprimat
gastrorezistent
Administrare oral
Danemarca Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac Diclopax 25mg Comprimat filmat Administrare oral
39

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac Diclopax 50mg Comprimat filmat Administrare oral
Danemarca Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac Diklotab 25mg Comprimat filmat Administrare oral
Danemarca Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac Diklotab 50mg Comprimat filmat Administrare oral
Danemarca Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac Eeze 25mg Comprimat filmat Administrare oral
Danemarca Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac Fenacta 12,5mg Comprimat filmat Administrare oral
Danemarca Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 50mg Comprimat filmat Administrare oral
Danemarca Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 25mg Comprimat filmat Administrare oral
40

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Danemarca Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup
Denmark
Diclofenac
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat Administrare oral
Danemarca Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup
Denmark
Diclofenac
Misoprostol
Arthrotec Forte 75mg
0.2mg
Comprimat Administrare oral
Estonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac DICLOBERL
75MG/3ML
25mg/ml Soluie injectabil Administrare
intramuscular
Estonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac DICLOBERL RETARD 100mg Capsul cu
eliberare
prelungit
Administrare oral
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac DICLOMELAN 50 MG 50mg Comprimat
gastrorezistent
Administrare oral
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac DICLOMELAN 100mg Supozitor Administrare
rectal
41

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac DICLOMELAN
RETARD 100 MG
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Estonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac NAKLOFEN 50mg Comprimat
gastrorezistent
Administrare oral
Estonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac NAKLOFEN 50mg Supozitor Administrare
rectal
Estonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac NAKLOFEN 25mg/ml Soluie injectabil Administrare
intramuscular
Estonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac NAKLOFEN SR 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Estonia Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac ALMIRAL 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
42

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Estonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac OLFEN DEPOCAPS 100mg Capsul cu
eliberare
prelungit
Administrare oral
Estonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac OLFEN DEPOCAPS 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Estonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac CATAFLAM 50mg Drajeu Administrare oral
Estonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac VOLTAREN 25mg/ml Soluie injectabil Administrare
intramuscular
Estonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac VOLTAREN RETARD 100mg Comprimat cu
eliberare
prelungit
Administrare oral
43

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Estonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac VOLTAREN AKTI 12,5mg Comprimat filmat Administrare oral
Estonia Pfizer Enterprises SARL
Round-Point du Kirchberg
51, Avenue J.F.Kennedy
L-1855 Luxembourg
Luxembourg
Diclofenac
Misoprostol
ARTHROTEC 50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
Estonia Pharmaswiss Eesti O
Tammsaare tee 47
11316 Tallinn
Estonia
Diclofenac DICLORAPID 75mg Capsul
gastrorezistent
Administrare oral
Estonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac DICLOFENAC-
RATIOPHARM 50MG
50mg Comprimat
gastrorezistent
Administrare oral
Estonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac DICLOFENAC-
RATIOPHARM 50MG
50mg Supozitor Administrare
rectal
Estonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac DICLOFENAC-
RATIOPHARM 100
MG
100mg Supozitor Administrare
rectal
Estonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac DICLOFENAC-
RATIOPHARM
75MG/2ML
75mg/2ml Soluie injectabil Administrare
intramuscular
44

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Estonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac DICLOFENAC-
RATIOPHARM UNO
150mg Comprimat cu
eliberare
modificat
Administrare oral
Estonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac DICLAC 100 100mg Supozitor Administrare
rectal
Estonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac DICLAC 25mg/ml Soluie injectabil Administrare
intramuscular
Estonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac DICLAC ID 75 MG 75mg Comprimat cu
eliberare
modificat
Administrare oral
Estonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac DICLAC ID 150 MG 150mg Comprimat cu
eliberare
modificat
Administrare oral
Estonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac DICLAC 100 MG 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Estonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac DICUNO 25mg Comprimat filmat Administrare oral
45

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Estonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac DICUNO 50mg Comprimat filmat Administrare oral
Finlanda Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac potasic Diclofenac Rapid
Orifarm
50mg Comprimat filmat Administrare oral
Finlanda ratiopharm Oy
P.O.Box 67
02631 Espoo
Finland
Diclofenac potasic Diclomex Rapid 50mg Comprimat filmat Administrare oral
Finlanda Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 25mg Comprimat filmat Administrare oral
Finlanda Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 50mg Comprimat filmat Administrare oral
Finlanda Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac potasic Eeze 25mg Comprimat filmat Administrare oral
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Voltaren Rapid 25mg Drajeu Administrare oral
46

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Voltaren Rapid 50mg Drajeu Administrare oral
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Voltfast 50mg Pulbere pentru
soluie oral
Administrare oral
Finlanda Pfizer Oy
Tietokuja 4
00330 Helsinki
Finland
Diclofenac sodic
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat Administrare oral
Finlanda Pfizer Oy
Tietokuja 4
00330 Helsinki
Finland
Diclofenac sodic
Misoprostol
Arthrotec Forte 75mg
0.2mg
Comprimat cu
eliberare
prelungit
Administrare oral
Finlanda BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
25mg Comprimat
gastrorezistent
Administrare oral
Finlanda BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
50mg Comprimat
gastrorezistent
Administrare oral
Finlanda ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclomex 25mg Comprimat
gastrorezistent
Administrare oral
47

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Finlanda ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclomex 50mg Comprimat
gastrorezistent
Administrare oral
Finlanda Oy Stada Pharma Ab
P.O.Box 1310
00101 Helsinki
Finland
Diclofenac sodic Motifene Dual 75mg Capsul cu
eliberare
prelungit
Administrare oral
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren 25mg/ml Soluie injectabil
/Concentrat
pentru soluie
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
48

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Finlanda Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren Retard 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Frana Laboratoires Genevrier
280, rue de Goa
Les Trois Moulins - Parc de
Sophia Antipolis
06600 Antibes
France
Diclofenac
epolamine
FLECTOR 25 mg,
granuls pour
solution buvable en
sachet-dose
25mg Granule pentru
soluie oral
Administrare oral
Frana Laboratoires Genevrier
280, rue de Goa
Les Trois Moulins - Parc de
Sophia Antipolis
06600 Antibes
France
Diclofenac
epolamine
FLECTOR 50 mg,
granuls pour
solution buvable en
sachet-dose
50mg Granule pentru
soluie oral
Administrare oral
Frana Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic DICLOFENAC
ACTAVIS 12,5 mg,
comprim pellicul
12,5mg Comprimat filmat Administrare oral
Frana NOVARTIS SANTE
FAMILIALE
14, boulevard Richelieu
92500 Rueil-Malmaison
France
Diclofenac potasic VOLTARENDOLO
12,5 mg, comprim
enrob
12,5mg Drajeu Administrare oral
Frana ARROW GENERIQUES
26, avenue Tony Garnier
69007 Lyon
France
Diclofenac sodic DICLOFENAC
ARROW 50 mg,
comprim gastro-
rsistant
50mg Comprimat
gastrorezistent
Administrare oral
49

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Frana BIOGARAN
15, boulevard Charles de
Gaulle
92700 Colombes
France
Diclofenac sodic DICLOFENAC
BIOGARAN 50 mg,
comprim pellicul
gastrorsistant
50mg Comprimat filmat
gastrorezistent
Administrare oral
Frana SANDOZ
49, avenue Georges
Pompidou
92300 Levallois-Perret
France
Diclofenac sodic DICLOFENAC
BIOSTABILEX 50
mg, comprim
gastro-rsistant
50mg Comprimat
gastrorezistent
Administrare oral
Frana CRISTERS
22 quai Gallieni
92150 Suresnes
France
Diclofenac sodic DICLOFENAC
CRISTERS 50 mg,
comprim gastro-
rsistant
50mg Comprimat
gastrorezistent
Administrare oral
Frana EG LABO - LABORATOIRES
EUROGENERICS
"Le Quintet" - btiment A
12, rue Danjou
92517 Boulogne Billancourt
Cedex
France
Diclofenac sodic DICLOFENAC EG 50
mg,comprim
gastro-rsistant
50mg Comprimat
gastrorezistent
Administrare oral
Frana MYLAN SAS
117, alle des Parcs
69800 Saint-Priest
France
Diclofenac sodic DICLOFENAC MYLAN
25 mg, comprim
gastro-rsistant
25mg Comprimat
gastrorezistent
Administrare oral
Frana MYLAN SAS
117, alle des Parcs
69800 Saint-Priest
France
Diclofenac sodic DICLOFENAC MYLAN
50 mg, comprim
gastro-rsistant
50mg Comprimat
gastrorezistent
Administrare oral
50

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Frana SANDOZ
49, avenue Georges
Pompidou
92300 Levallois-Perret
France
Diclofenac sodic DICLOFENAC
SANDOZ 50 mg,
comprim enrob
gastro-rsistant
50mg Comprimat
gastrorezistent
Administrare oral
Frana TEVA SANTE
110, Esplanade du Gnral
de Gaulle
92931 Paris La Dfense
Cedex
France
Diclofenac sodic DICLOFENAC TEVA
25 mg, comprim
enrob gastro-
rsistant
25mg Comprimat
gastrorezistent
Administrare oral
Frana TEVA SANTE
110, Esplanade du Gnral
de Gaulle
92931 Paris La Dfense
Cedex
France
Diclofenac sodic DICLOFENAC TEVA
50 mg, comprim
enrob gastro-
rsistant
50mg Comprimat
gastrorezistent
Administrare oral
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE 100 mg,
suppositoire
100mg Supozitor Administrare
rectal
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE 25 mg,
comprim gastro-
rsistant
25mg Comprimat
gastrorezistent
Administrare oral
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE 50 mg,
comprim enrob
gastro-rsistant
50mg Comprimat
gastrorezistent
Administrare oral
51

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE 75
mg/3 ml, solution
injectable
75mg/3ml Soluie injectabil Administrare
intramuscular
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE
ENFANT,
suppositoire
25mg Supozitor Administrare
rectal
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE LP 100
mg, comprim
enrob libration
prolonge
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Frana NOVARTIS PHARMA
2-4, rue Lionel Terray
92500 Rueil-Malmaison
France
Diclofenac sodic VOLTARENE LP 75
mg, comprim
enrob libration
prolonge
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Frana Pfizer Holding France
23-25, avenue du Docteur
Lannelongue
75014 Paris
France
Diclofenac sodic
Misoprostol
ARTOTEC 50 mg/0,2
mg, comprim
gastro-rsistant
50mg
0,2mg
Comprimat
gastrorezistent
Administrare oral
Frana Pfizer Holding France
23-25, avenue du Docteur
Lannelongue
75014 Paris
France
Diclofenac sodic
Misoprostol
ARTOTEC 75 mg/0,2
mg, comprim
gastro-rsistant
75mg
0.2mg
Comprimat
gastrorezistent
Administrare oral
52

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Frana TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Diclofenac sodic Xelaran
Brausetablette 25
mg
25mg Comprimat
efervescent
Administrare oral
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclo 100 retard - 1
A Pharma
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclo 25 - 1 A
Pharma
25mg Comprimat
gastrorezistent
Administrare oral
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclo 50 - 1 A
Pharma
50mg Comprimat
gastrorezistent
Administrare oral
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclo 75 SL - 1 A
Pharma
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclofenac- 1 A
Pharma 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania 1 A Pharma
Keltenring 1+3
82041 Oberhaching
Germany
Diclofenac sodic Diclofenac- 1 A
Pharma 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
53

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania AbZ-Pharma GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclofenac AbZ 25
mg Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Germania AbZ-Pharma GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclofenac AbZ 50
mg Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania AbZ-Pharma GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclofenac AbZ 50
mg Trinktabletten
50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania Actavis Deutschland GmbH &
Co. KG
Willy-Brandt-Allee 2
81829 Mnchen
Germany
Diclofenac sodic Diclo Divido 75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Actavis Deutschland GmbH &
Co. KG
Willy-Brandt-Allee 2
81829 Mnchen
Germany
Diclofenac sodic Diclo-Divido long 75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Actavis Deutschland GmbH &
Co. KG
Willy-Brandt-Allee 2
81829 Mnchen
Germany
Diclofenac sodic Diclofenac-Actavis
100 mg
100mg Capsul cu
eliberare
prelungit
Administrare oral
54

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Actavis Deutschland GmbH &
Co. KG
Willy-Brandt-Allee 2
81829 Mnchen
Germany
Diclofenac sodic Diclofenac-Actavis
50 mg
50mg Capsul
gastrorezistent
Administrare oral
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac potasic Diclo AL akut 12,5
mg
12,5mg Comprimat filmat Administrare oral
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL 100 100mg Supozitor Administrare
rectal
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL 25 25mg Comprimat
gastrorezistent
Administrare oral
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL 50 50mg Comprimat
gastrorezistent
Administrare oral
55

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL 50
Supp.
50mg Supozitor Administrare
rectal
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL i.m. 75mg Soluie injectabil Administrare
intramuscular
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac sodic Diclofenac AL retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac potasic Diclofenac-Kalium
AL 25 mg
Filmtabletten
25mg Comprimat filmat Administrare oral
Germania AWD.pharma GmbH &
Co. KG
Wasastr. 50
01445 Radebeul
Germany
Diclofenac sodic Rewodina 25mg 25mg Comprimat
gastrorezistent
Administrare oral
56

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania AWD.pharma GmbH &
Co. KG
Wasastr. 50
01445 Radebeul
Germany
Diclofenac sodic Rewodina 50mg 50mg Comprimat
gastrorezistent
Administrare oral
Germania AWD.pharma GmbH &
Co. KG
Wasastr. 50
01445 Radebeul
Germany
Diclofenac sodic Rewodina dual 75
Kaps
75mg Capsul Administrare oral
Germania AWD.pharma GmbH &
Co. KG
Wasastr. 50
01445 Radebeul
Germany
Diclofenac sodic Rewodina uno 100 100mg Capsul Administrare oral
Germania AWD.pharma GmbH &
Co. KG
Wasastr. 50
01445 Radebeul
Germany
Diclofenac sodic Xelaran
Brausetablette 50
mg
50mg Comprimat
efervescent
Administrare oral
Germania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
57

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 50 mg
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl N 75 75mg Soluie injectabil Administrare
intramuscular
Germania betapharm Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Diclofenac sodic Diclo dispers 50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania betapharm Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Diclofenac sodic Diclofenbeta 100 100mg Supozitor Administrare
rectal
Germania betapharm Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Diclofenac sodic Diclofenbeta 100
retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
58

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania betapharm Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Diclofenac sodic Diclofenbeta 25 25mg Comprimat
gastrorezistent
Administrare oral
Germania betapharm Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Diclofenac sodic Diclofenbeta 50 50mg Comprimat
gastrorezistent
Administrare oral
Germania Chephasaar Chemisch-
Pharmazeutische Fabrik
GmbH
Muehlstr. 50
66386 Sankt Ingbert
Germany
Diclofenac sodic Diclo-saar 100 mg
Retardtablette
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Chephasaar Chemisch-
Pharmazeutische Fabrik
GmbH
Muehlstr. 50
66386 Sankt Ingbert
Germany
Diclofenac sodic Diclo-saar 50 mg
magensaftresistente
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania Chephasaar Chemisch-
Pharmazeutische Fabrik
GmbH
Muehlstr. 50
66386 Sankt Ingbert
Germany
Diclofenac sodic Diclo-saar 75mg SF
Injektionslsung
75mg Soluie injectabil Administrare
intramuscular
59

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 100 mg
Supp.
100mg Supozitor Administrare
rectal
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 25 mg
Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 50 mg
Trinktabletten
50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 50mg
Supp.
50mg Supozitor Administrare
rectal
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 50mg
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo-CT 75mg/2ml
Ampullen
75mg Soluie injectabil Administrare
intramuscular
Germania CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac potasic Diclo-CT akut 12,5
mg Filmtabletten
12,5mg Comprimat filmat Administrare oral
60

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Denk Pharma GmbH & Co.
KG
Prinzregentenstr. 79
81675 Mnchen
Germany
Diclofenac sodic Diclo-Denk 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania Denk Pharma GmbH & Co.
KG
Prinzregentenstr. 79
81675 Mnchen
Germany
Diclofenac sodic DICLO-DENK 100mg
RETARD
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Dexcel Pharma GmbH
Carl-Zeiss-Str. 2
63755 Alzenau
Germany
Diclofenac sodic Diclofenac Atid
50mg
50mg Comprimat
gastrorezistent
Administrare oral
Germania Dexcel Pharma GmbH
Carl-Zeiss-Str. 2
63755 Alzenau
Germany
Diclofenac sodic Diclofenac Atid
retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania DOCPHARM
Arzneimittelvertrieb GmbH &
Co.
Kommanditgesellschaft auf
Aktien
Greschbachstr. 7
76229 Karlsruhe
Germany
Diclofenac sodic Diclafenac PB retard
100mg
100mg Comprimat cu
eliberare
prelungit
Administrare oral
61

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
Germany
Diclofenac sodic Dolgit-Diclo 100 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Dolorgiet GmbH & Co. KG
Otto-von-Guericke-Str. 1
53757 Sankt Augustin
Germany
Diclofenac sodic Dolgit-Diclo 50 50mg Comprimat
gastrorezistent
Administrare oral
Germania Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac sodic Myogit 100 100mg Supozitor Administrare
rectal
Germania Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac sodic Myogit 25 25mg Comprimat
gastrorezistent
Administrare oral
Germania Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac sodic Myogit 50 50mg Comprimat
gastrorezistent
Administrare oral
62

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Dr. Kade Pharmazeutische
Fabrik GmbH
Rigistr. 2
12277 Berlin
Germany
Diclofenac sodic Diclo KD 100 100mg Supozitor Administrare
rectal
Germania Dr. Kade Pharmazeutische
Fabrik GmbH
Rigistr. 2
12277 Berlin
Germany
Diclofenac sodic Diclo KD 50 50mg Supozitor Administrare
rectal
Germania Dr. Kade Pharmazeutische
Fabrik GmbH
Rigistr. 2
12277 Berlin
Germany
Diclofenac sodic Diclo KD 50 50mg Comprimat
gastrorezistent
Administrare oral
Germania Dr. Kade Pharmazeutische
Fabrik GmbH
Rigistr. 2
12277 Berlin
Germany
Diclofenac sodic Diclo KD 75 akut 75mg Capsul cu
eliberare
modificat
Administrare oral
Germania Dr. Kade Pharmazeutische
Fabrik GmbH
Rigistr. 2
12277 Berlin
Germany
Diclofenac sodic Diclo KD retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania hameln pharma plus gmbh
Langes Feld 13
31789 Hameln
Germany
Diclofenac sodic Diclo-Weimer 75mg Soluie injectabil Administrare
intramuscular
63

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Hermes Arzneimittel GmbH
Georg-Kalb-Str. 5-8
82049 Grohesselohe
Germany
Diclofenac sodic Diclofenac Natrium
HERMES 25 mg
Brausetabletten
25mg Comprimat
efervescent
Administrare oral
Germania Hermes Arzneimittel GmbH
Georg-Kalb-Str. 5-8
82049 Grohesselohe
Germany
Diclofenac sodic Diclofenac Natrium
HERMES 50 mg
Brausetabletten
50mg Comprimat
efervescent
Administrare oral
Germania Heumann Pharma GmbH &
Generica Co. KG
Sdwestpark 50
90449 Nrnberg
Germany
Diclofenac sodic Diclofenac 100
Heumann Supp.
100mg Supozitor Administrare
rectal
Germania Heumann Pharma GmbH &
Generica Co. KG
Sdwestpark 50
90449 Nrnberg
Germany
Diclofenac sodic Diclofenac 100
retard Heumenn
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Heumann Pharma GmbH &
Generica Co. KG
Sdwestpark 50
90449 Nrnberg
Germany
Diclofenac sodic Diclofenac 25
Heumenn
25mg Comprimat
gastrorezistent
Administrare oral
Germania Heumann Pharma GmbH &
Generica Co. KG
Sdwestpark 50
90449 Nrnberg
Germany
Diclofenac sodic Diclofenac 50
Heumann
50mg Comprimat
gastrorezistent
Administrare oral
64

Statul Membru
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Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Heumann Pharma GmbH &
Generica Co. KG
Sdwestpark 50
90449 Nrnberg
Germany
Diclofenac sodic Diclofenac 50
Heumenn Supp.
50mg Supozitor Administrare
rectal
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 75mg Soluie injectabil Administrare
intramuscular
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 100mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 150 mg ID 150mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 25 25mg Comprimat
gastrorezistent
Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 50 50mg Comprimat
gastrorezistent
Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
65

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 75 mg ID 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac Dispers 50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac potasic Diclac Dolo 12,5 mg 12,5mg Comprimat filmat Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac potasic Diclac Dolo 25 mg 25mg Drajeu Administrare oral
Germania Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania HIKMA Farmaceutica
(Portugal(, S.A.
Estrada do Rio da Mo, 8, 8 A
e 8 B - Fervenca
2705-906 Terrugem SNT
Portugal
Diclofenac sodic Diclofenac Hikma 75
mg
75mg Soluie injectabil Administrare
intramuscular
66

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Juta Pharma GmbH
Gutenbergstr. 13
24941 Flensburg
Germany
Diclofenac sodic Jutafenac 100 mg
Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Kappler Pharma Consult
GmbH
Fonyoder Str. 18
89340 Leipheim
Germany
Diclofenac potasic Diclofen Kalium KPC
25 mg Filmtabletten
25mg Comprimat filmat Administrare oral
Germania KSK-Pharma Vertriebs AG
Finkenstr. 1
76327 Pfinztal-Berghausen
Germany
Diclofenac sodic Diclo KSK 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Germania MEDA Pharma GmbH & Co.
KG
Benzstr. 1
61352 Bad Homburg
Germany
Diclofenac sodic Diclofenac MEDA 25
mg Brausetabletten
25mg Comprimat
efervescent
Administrare oral
Germania MEDA Pharma GmbH & Co.
KG
Benzstr. 1
61352 Bad Homburg
Germany
Diclofenac sodic Diclofenac MEDA 50
mg Brausetabletten
50mg Comprimat
efervescent
Administrare oral
Germania Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
Diclofenac sodic Diclofenac dura 100
mg Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
67

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
Diclofenac sodic Diclofenac dura 100
mg Zpfchen
100mg Supozitor Administrare
rectal
Germania Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
Diclofenac sodic Diclofenac dura 25
mg
25mg Comprimat
gastrorezistent
Administrare oral
Germania Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
Diclofenac sodic Diclofenac dura 50
mg
50mg Comprimat
gastrorezistent
Administrare oral
Germania Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
Diclofenac sodic Diclofenac Mylan
100 mg
Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Diclofenac NCH 25
mg
25mg Drajeu Administrare oral
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Optalidon
Zahnschmerz mit
Diclofenac 25 mg
25mg Drajeu Administrare oral
68

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Voltaren Dolo 12,5
mg
12,5mg Comprimat filmat Administrare oral
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Voltaren Dolo 25 mg 25mg Drajeu Administrare oral
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Voltaren Dolo 25 mg 25mg Drajeu Administrare oral
Germania Novartis Consumer Health
GmbH
Zielstattstrasse 40
81379 Mnchen
Germany
Diclofenac potasic Voltaren Dolo Liquid
12,5 mg
12,5mg Capsul moale Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic
Codein hemihidrat
fosfat
Combaren 50 mg/50
mg Filmtabletten
50 mg
50 mg
Comprimat filmat Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 100 mg
retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
69

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 25 mg 25mg Comprimat
gastrorezistent
Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 25 mg
Zpfchen
25mg Supozitor Administrare
rectal
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic Voltaren Dispers 50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac potasic Voltaren K Migrne
50mg
50mg Drajeu Administrare oral
70

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac sodic
Codein hemihidrat
fosfat
Voltaren Plus
50mg/50mg
Filmtabletten
50 mg
50 mg
Comprimat filmat Administrare oral
Germania Novartis Pharma GmbH
Roonstrasse 25
90426 Nuernberg
Germany
Diclofenac
Colestiramin
Voltaren Resinat 140mg Capsul Administrare oral
Germania Pharmacia GmbH
Linkstrasse 10
10785 Berlin
Germany
Diclofenac sodic
Misoprostol
Arthotec 50mg
0,2mg
Drajeu Administrare oral
Germania Pharmacia GmbH
Linkstrasse 10
10785 Berlin
Germany
Diclofenac sodic
Misoprostol
Arthotec forte 75mg
0.2mg
Drajeu Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 100 mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 100 mg
Retardkapseln
100mg Capsul cu
eliberare
prelungit
Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 25 mg
magensaftresistente
Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
71

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 50 mg
Disperstabletten
50mg Comprimat
pentru dispersie
oral
Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 50 mg
magensaftresistente
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 75 mg
SL Retardkapseln
75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm
75mg/2ml
Injektionslsung
75mg/2ml Soluie injectabil Administrare
intramuscular
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac potasic Diclofenac-
ratiopharm Lsung
bei Migrne
50mg/1ml Picturi orale,
soluie
Administrare oral
Germania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac potasic Diclofenac-
ratiopharm
Schmerztabletten
12,5 mg
12,5mg Comprimat filmat Administrare oral
72

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Rotexmedica GmbH
Arzneimittelwerk
Bunsenstr. 4
22946 Trittau
Germany
Diclofenac sodic Diclofenac SF-
Rotexmedica
75mg/3ml Soluie injectabil Administrare
intramuscular
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
100 mg
Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
100 mg Zpfchen
100mg Supozitor Administrare
rectal
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
25 mg
magensaftresistente
Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
50 mg
magensaftresistente
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
73

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
50 mg Zpfchen
50mg Supozitor Administrare
rectal
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
parenteral 75mg
Injektionslsung
75mg Soluie injectabil Administrare
intramuscular
Germania Sandoz Pharmaceuticals
GmbH
Raiffeisenstr. 11
83607 Holzkirchen
Germany
Diclofenac sodic Diclofenac Sandoz
Uno 150 mg
Retardtabletten
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania sigapharm GmbH
Temmlerstr. 2
35039 Marburg/Lahn
Germany
Diclofenac sodic Sigafenac 50 mg
Zpfchen
50mg Supozitor Administrare
rectal
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac STADA
100 mg
Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac STADA
100 mg Zpfchen
100mg Supozitor Administrare
rectal
74

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac STADA
25mg
magensaftresistente
Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac STADA
50mg
magensaftresistente
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac Stada
50mg Zpfchen
50mg Supozitor Administrare
rectal
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac sodic Diclofenac STADA N
75 mg/3 ml
Injektionslsung
75mg/3ml Soluie injectabil Administrare
intramuscular
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac potasic Diclofenac-Kalium
STADA 12,5 mg
Filmtabletten
12,5mg Comprimat filmat Administrare oral
Germania Stadapharm GmbH
Stadastr. 2-18
61118 Bad Vilbel
Germany
Diclofenac potasic Diclofenac-Kalium
STADA 25 mg
Filmtabletten
25mg Comprimat filmat Administrare oral
Germania T & D Pharma GmbH
Kleine Knopheide 4
32657 Lemgo
Germany
Diclofenac sodic Allvoran 100 mg
Retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
75

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania T & D Pharma GmbH
Kleine Knopheide 4
32657 Lemgo
Germany
Diclofenac sodic Allvoran SF 75mg/3ml Soluie injectabil Administrare
intramuscular
Germania TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
Diclofenac sodic Allvoran 25mg 25mg Comprimat
gastrorezistent
Administrare oral
Germania TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
Diclofenac sodic Allvoran 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Germania TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
Diclofenac sodic Allvoran S 100mg 100mg Supozitor Administrare
rectal
Germania TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
Diclofenac sodic Allvoran S 50 mg 50mg Supozitor Administrare
rectal
Germania TAD Pharma GmbH
Heinz-Lohmann-Str. 5
27472 Cuxhaven
Germany
Diclofenac sodic Allvoran uno 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclo-Klinge 75mg
magensaftresistente
Hartkapsel
75mg Capsul cu
eliberare
prelungit
Administrare oral
76

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclo-Klinge 75mg
spezial
75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclofenac spezial
100mg Klinge
100mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclofenac spezial
75mg Klinge
75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclofenac Temmler
25 mg Hartkapseln
25mg Capsul
gastrorezistent
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclofenac Temmler
SL 100mg
Retardkapseln
100mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Temmler Werke GmbH
Weihenstephaner Str. 28
81673 Mnchen
Germany
Diclofenac sodic Diclofenac Temmler
SL 75mg
Retardkapseln
75mg Capsul cu
eliberare
prelungit
Administrare oral
Germania TEOFARMA S.R.L.
Via F.Iii Cervi 8
I-27010 VALLE SALIMBENE
(PV)
Italy
Diclofenac sodic Effekton 100 mg
Retardtabletten
100mg Comprimat cu
eliberare
prelungit
Administrare oral
77

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania TEOFARMA S.R.L.
Via F.Iii Cervi 8
I-27010 VALLE SALIMBENE
(PV)
Italy
Diclofenac sodic Effekton 100mg
Zpfchen
100mg Supozitor Administrare
rectal
Germania TEOFARMA S.R.L.
Via F.Iii Cervi 8
I-27010 VALLE SALIMBENE
(PV)
Italy
Diclofenac sodic Effekton 25 mg
magensaftresistente
Tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Germania TEOFARMA S.R.L.
Via F.Iii Cervi 8
I-27010 VALLE SALIMBENE
(PV)
Italy
Diclofenac sodic Effekton 50 mg
magensaftresistente
Tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Germania TEOFARMA S.R.L.
Via F.Iii Cervi 8
I-27010 VALLE SALIMBENE
(PV)
Italy
Diclofenac sodic Effekton 75mg/3ml
Injektionslsung
75mg/3ml Soluie injectabil Administrare
intramuscular
Germania TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Diclofenac sodic Xelaran
Brausetablette 25
mg
25mg Comprimat
efervescent
Administrare oral
Germania Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Diclotin 25 mg
Filmtabletten
25mg Comprimat filmat Administrare oral
78

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Diclotin 50 mg
Filmtabletten
50mg Comprimat filmat Administrare oral
Germania Walter Ritter GmbH & Co.
Spaldingstr. 110 B
20097 Hamburg
Germany
Diclofenac sodic Diclowal 100mg
retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Walter Ritter GmbH & Co.
Spaldingstr. 110 B
20097 Hamburg
Germany
Diclofenac sodic DICLOWAL 50 50mg Comprimat
gastrorezistent
Administrare oral
Germania Walter Ritter GmbH & Co.
Spaldingstr. 110 B
20097 Hamburg
Germany
Diclofenac sodic DICLOWAL 75 mg 75mg Soluie injectabil Administrare
intramuscular
Germania Walter Ritter GmbH & Co.
Spaldingstr. 110 B
20097 Hamburg
Germany
Diclofenac sodic DICLOWAL Supp. 100mg Supozitor Administrare
rectal
Germania Winthrop Arzneimittel GmbH
Urmitzer Str. 5
56218 Mlheim-Krlich
Germany
Diclofenac sodic Monoflam 100mg 100mg Supozitor Administrare
rectal
Germania Winthrop Arzneimittel GmbH
Urmitzer Str. 5
56218 Mlheim-Krlich
Germany
Diclofenac sodic Monoflam 50mg 50mg Comprimat
gastrorezistent
Administrare oral
79

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Germania Winthrop Arzneimittel GmbH
Urmitzer Str. 5
56218 Mlheim-Krlich
Germany
Diclofenac sodic Monoflam 50mg 50mg Supozitor Administrare
rectal
Germania Winthrop Arzneimittel GmbH
Urmitzer Str. 5
56218 Mlheim-Krlich
Germany
Diclofenac sodic Monoflam retard N 100mg Capsul cu
eliberare
prelungit
Administrare oral
Germania Wrwag Pharma GmbH &
Co.KG
Calwer Str. 7
71034 Bblingen
Germany
Diclofenac sodic Dignofenac 100 mg 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Germania Wrwag Pharma GmbH &
Co.KG
Calwer Str. 7
71034 Bblingen
Germany
Diclofenac sodic Dignofenac 25mg 25mg Comprimat
gastrorezistent
Administrare oral
Germania Wrwag Pharma GmbH &
Co.KG
Calwer Str. 7
71034 Bblingen
Germany
Diclofenac sodic Dignofenac 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Grecia PHARMACEUTICAL
INDUSTRY PROEL EPAM. G.
KORONIS
Dilou 9, Peristeri
Attikis, 12134
Greece
Diclofenac sodic BATAFIL 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
80

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia PHARMATHEN International
S.A.Greece
Dervenakiwn 4, Pallini
Attikis 15351
Greece
Diclofenac sodic DELIMON 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece
Diclofenac sodic VURDON 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia BROS EPE
Avgis & Gallinis 15
N. Kifissia, 14564
Greece
Diclofenac sodic EVINOPON 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia DEMO ABEE
21ST Km National Highway
Athens-Lamia, 14565
Greece
Diclofenac sodic URIGON 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia RAFARM AEBE
Korinthou 12
N. Psychiko, 15451
Greece
Diclofenac sodic RUVOMINOX 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
81

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia ANGELINI PHARMA HELLAS
S.A. of Manufacturing and
Commerce of Medicines
Achaias & Trizinias
Nea Kifissia 14564
Greece
Diclofenac sodic RHEUMAVEK 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia MEDICUS S.A
Valaoritou 10
Metamorfosi 14452
Greece
Diclofenac sodic DIFEND 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 50mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 100mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
82

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 75mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 50mg Comprimat
pentru dispersie
oral
Administrare oral
Grecia PHARMATHEN International
S.A.Greece
Dervenakiwn 4, Pallini
Attikis 15351
Greece
Diclofenac sodic DELIMON 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia PHARMATHEN International
S.A.Greece
Dervenakiwn 4, Pallini
Attikis 15351
Greece
Diclofenac sodic DELIMON 50mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia D.A.S.T. BIOTECH
Pharmaceutical Ltd
Larissis 10
Pallini 15351
Greece
Diclofenac sodic FLEFARMIN 50mg Comprimat filmat
gastrorezistent
Administrare oral
83

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece
Diclofenac sodic VURDON 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece
Diclofenac sodic VURDON 100mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Grecia BROS EPE
Avgis & Gallinis 15
N. Kifissia, 14564
Greece
Diclofenac sodic EVINOPON 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia BROS EPE
Avgis & Gallinis 15
N. Kifissia, 14564
Greece
Diclofenac sodic EVINOPON 50mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia DEMO ABEE
21ST Km National Highway
Athens-Lamia, 14565
Greece
Diclofenac sodic URIGON 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia DEMO ABEE
21ST Km National Highway
Athens-Lamia, 14565
Greece
Diclofenac sodic URIGON 50mg Comprimat filmat
gastrorezistent
Administrare oral
84

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia RAFARM AEBE
Korinthou 12
N. Psychiko, 15451
Greece
Diclofenac sodic RUVOMINOX 50mg Drajeu Administrare oral
Grecia RAFARM AEBE
Korinthou 12
N. Psychiko, 15451
Greece
Diclofenac sodic RUVOMINOX 25mg Drajeu Administrare oral
Grecia ANGELINI PHARMA HELLAS
S.A. of Manufacturing and
Commerce of Medicines
Achaias & Trizinias
Nea Kifissia 14564
Greece
Diclofenac sodic RHEUMAVEK 25mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia ANGELINI PHARMA HELLAS
S.A. of Manufacturing and
Commerce of Medicines
Achaias & Trizinias
Nea Kifissia 14564
Greece
Diclofenac sodic RHEUMAVEK 50mg Comprimat filmat
gastrorezistent
Administrare oral
Grecia Pfizer Hellas A.E.
Messoghion Ave. 243
Neo Psychiko 15451
Greece
Diclofenac sodic
Misoprostol
ARTHROTEC 50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
Grecia PHARMANEL COMMERCE
PHARMACEUTICAL S.A.
Marathonos Avenue 106,
Gerakas 15344
Greece
Diclofenac sodic FENOCLOF 75mg Capsul cu
eliberare
modificat
Administrare oral
85

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac potasic VOLTAREN ACTI-GO 25mg Drajeu Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac potasic VOLTAREN ACTI-GO 50mg Drajeu Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac potasic VOLTAREN ACTI-GO 12,5mg Drajeu Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac potasic VOLTAREN FAST 50mg Pulbere pentru
soluie oral
Administrare oral
Grecia PHARMASWISS HELLAS A.E.
Pentelis Avenue 53
Vrilissia 15235
Greece
Diclofenac sodic DICLO DUO 75mg Capsul cu
eliberare
modificat
Administrare oral
86

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia PHARMASWISS HELLAS A.E.
Pentelis Avenue 53
Vrilissia 15235
Greece
Diclofenac sodic COUNTERFLAME 75mg Capsul
gastrorezistent
Administrare oral
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 50mg Supozitor Administrare
rectal
Grecia NOVARTIS (HELLAS)
A.E.B.E.
12th Km National Highway
No 1, Metamorfosi Attikis
144 51
Greece
Diclofenac sodic VOLTAREN 100mg Supozitor Administrare
rectal
Grecia HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece
Diclofenac sodic VURDON 50mg Supozitor Administrare
rectal
Grecia HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece
Diclofenac sodic VURDON 100mg Supozitor Administrare
rectal
87

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Grecia BROS EPE
Avgis & Gallinis 15
N. Kifissia, 14564
Greece
Diclofenac sodic EVINOPON 50mg Supozitor Administrare
rectal
Grecia RAFARM AEBE
Korinthou 12
N. Psychiko, 15451
Greece
Diclofenac sodic RUVOMINOX 50mg Supozitor Administrare
rectal
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac CATAFLAM
belsleges
szuszpenzis
cseppek
15mg/ml Picturi orale,
suspensie
Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac CATAFLAM 50 mg
bevont tabletta
50mg Drajeu Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac CATAFLAM-V 50 mg
tabletta
50mg Comprimat Administrare oral
Ungaria Sandoz Hungria Kft., .,
Bartk Bla t 43.-47.
Budapest, 1114
Hungary
Diclofenac DICLAC 75 mg
retard tabletta
75mg Comprimat cu
eliberare
prelungit
Administrare oral
88

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Ungaria Sandoz Hungria Kft., .,
Bartk Bla t 43.-47.
Budapest, 1114
Hungary
Diclofenac DICLAC 150 mg
retard tabletta
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Ungaria ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac DICLOFENAC AL 50
mg vgblkp
50mg Supozitor Administrare
rectal
Ungaria ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac DICLOFENAC AL 50
mg gyomornedv-
ellenll filmtabletta
50mg Comprimat filmat
gastrorezistent
Administrare oral
Ungaria ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac DICLOFENAC AL 100
mg vgblkp
100mg Supozitor Administrare
rectal
Ungaria ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac DICLOFENAC AL 75
mg/3 ml oldatos
injekci
75mg/3ml Soluie injectabil Parenteral,
Administrare
intramuscular
Ungaria PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac DICLOFENAC DUO
PHARMAVIT 75 mg
kemny kapszula
75mg Capsul Administrare oral
89

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Ungaria STADA Arzneimittel AG
Stadastrasse 2-18
Bad Vilbel 61118
Germany
Diclofenac DICLOFENAC STADA
100 mg retard
filmtabletta
100mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Ungaria ratiopharm Hungria
Kereskedelmi Kft. Uzsoki u.
36/a
Budapest, 1145
Hungary
Diclofenac DICLOFENAC-
RATIOPHARM 25 mg
filmtabletta
25mg Comprimat filmat Administrare oral
Ungaria ratiopharm Hungria
Kereskedelmi Kft. Uzsoki u.
36/a
Budapest, 1145
Hungary
Diclofenac DICLOFENAC-
RATIOPHARM 100
mg retard kemny
kapszula
100mg Capsul cu
eliberare
prelungit
Administrare oral
Ungaria ratiopharm Hungria
Kereskedelmi Kft. Uzsoki u.
36/a
Budapest, 1145
Hungary
Diclofenac DICLOFENAC-
RATIOPHARM 50 mg
filmtabletta
50mg Comprimat filmat Administrare oral
Ungaria ratiopharm Hungria
Kereskedelmi Kft. Uzsoki u.
36/a
Budapest, 1145
Hungary
Diclofenac DICLOFENAC-
RATIOPHARM retard
tabletta
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Ungaria TEVA Gygyszergyr zRt.
Pallagi t 13
Debrecen 4042
Hungary
Diclofenac DICLOFENAC-TEVA
100 mg vgblkp
100mg Supozitor Administrare
rectal
90

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Ungaria PANNONPHARMA
Gygyszergyrt Kft.
PannonPharma t 1.
Pcsvrad 7720
Hungary
Diclofenac DICLOMEL SR 100
mg retard tabletta
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Ungaria Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic
Orfenadrin citrat
NEODOLPASSE
oldatos infzi
75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
parenteral,
Administrare
intravenoas
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 100 mg
retard filmtabletta
100mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 25 mg
gyomornedv-
ellenll filmtabletta
25mg Comprimat filmat
gastrorezistent
Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 50 mg
gyomornedv-
ellenll filmtabletta
50mg Comprimat filmat
gastrorezistent
Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 50 mg
vgblkp
50mg Supozitor Administrare
rectal
91

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 75 mg
retard filmtabletta
75mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN 75 mg/3
ml oldatos injekci
75mg/3ml Soluie injectabil Administrare
parenteral;
Injecie
intramuscular sau
perfuzie
intravenoasa. Nu
se aplic pentru
injectarea
intravenoas n
bolus
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN DOLO
12,5 mg filmtabletta
12,5mg Comprimat filmat Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN DOLO
12,5 mg lgy
kapszula
12,5mg Capsul moale Administrare oral
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac VOLTAREN DOLO 25
mg bevont tabletta
25mg Drajeu Administrare oral
92

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Ungaria Novartis Hungria Kft.
Pharma rszlege
Bartk Bla t 43-47.
Budapest, 1114
Hungary
Diclofenac potasic VOLTAREN DOLO 25
mg lgy kapszula
25mg Capsul moale Administrare oral
Ungaria IBSA Pharma Informcis s
Szolgltat Kft.
Fodor u. 54/B.
Budapest 1124,
Hungary
Diclofenac FLECTOR RAPID 50
mg granultum
50mg Granule Administrare oral
Ungaria TEVA Gygyszergyr zRt.
Pallagi t 13
Debrecen 4042
Hungary
Diclofenac FORTEDOL 50 mg
filmtabletta
50mg Comprimat filmat Administrare oral
Islanda Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup
Denmark
Diclofenac sodic
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat Administrare oral
Islanda Pfizer ApS
Lautrupvang 8
DK-2750 Ballerup
Denmark
Diclofenac sodic
Misoprostol
Arthrotec Forte 75mg
0.2mg
Comprimat Administrare oral
Islanda ratiopharm GmbH
Graf-Arco Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclomex 50 mg Comprimat
gastrorezistent
Administrare oral
93

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Islanda Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac sodic Diklofenak Mylan 50mg Comprimat
gastrorezistent
Administrare oral
Islanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac sodic Klofen L 100mg Capsul cu
eliberare
prelungit
Administrare oral
Islanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac sodic Modifenac 75mg Capsul cu
eliberare
modificat
Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac sodic Voltaren 25mg/ml Soluie injectabil Administrare
intramuscular
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
94

Statul Membru
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Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac potasic Voltaren Dolo 12,5mg Comprimat filmat Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac potasic Voltaren Dolo 12,5mg Capsul moale Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac potasic Voltaren Dolo 25mg Drajeu Administrare oral
Islanda Novaris Healthcare A/S
Lyngbyvej 172
DK-2100 Kbenhawn
Denmark
Diclofenac potasic Voltaren Rapid 50mg Drajeu Administrare oral
Islanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Vstar-S 25mg Comprimat filmat Administrare oral
Islanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Vstar-S 50mg Comprimat filmat Administrare oral
95

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol 25 mg
Gastro-Resistant
Tablets
25mg Comprimat
gastrorezistent
Administrare oral
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol 50 mg
Gastro-Resistant
Tablets
50mg Comprimat
gastrorezistent
Administrare oral
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol 12.5mg
Suppositories
12,5mg Supozitor Administrare
rectal
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol 100mg
Suppositories
100mg Supozitor Administrare
rectal
96

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol Ampoules
75mg/3ml, solution
for injection
75mg/3ml Soluie injectabil Administrare
intramuscular
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol Retard 100
mg Film-coated
Prolonged Release
Tablets
100mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac sodic Voltarol Retard 75
mg Film-coated
Prolonged-release
Tablets
75mg Comprimat filmat
cu eliberare
prelungit
Administrare oral
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac potasic Cataflam 25mg
Coated Tablets
25mg Drajeu Administrare oral
97

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac potasic Cataflam 50 mg
Coated Tablets
50mg Drajeu Administrare oral
Irlanda Novarits Pharmacetucials UK
Ltd
Frimley Business Park
Frimley
Camberley, GU16 7SR
Surrey
United Kingdom
Diclofenac potasic Voltfast Sachets 50
mg Powder for Oral
Solution
50mg Pulbere pentru
soluie oral
Administrare oral
Irlanda Novartis Consumer Health
UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom
Diclofenac potasic Diclofenac
potassium NCH
12.5mg Film-coated
tablets
12,5mg Comprimat filmat Administrare oral
Irlanda Novartis Consumer Health
UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom
Diclofenac potasic Otriflu 12.5mg Film-
coated Tablets
12,5mg Comprimat filmat Administrare oral
98

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Pinewood Laboratories Ltd
(T/A Pinewood Heathcare)
Ballymacarbry
Clonmel, Co. Tipperary
Ireland
Diclofenac sodic Diclo 75mg
prolonged release
tablets.
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac 75 mg
Prolonged -Release
Tablets
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac Retard 100
mg Prolonged-
release Tablets
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac 25 mg
Gastro-resistant
Tablets
25mg Comprimat
gastrorezistent
Administrare oral
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac 50 mg
Gastro-resistant
Tablets
50mg Comprimat
gastrorezistent
Administrare oral
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac 100 mg
Suppositories
100mg Supozitor Administrare
rectal
Irlanda Rowex Ltd
Bantry, Co. Cork
Ireland
Diclofenac sodic Diclac 25 mg/ml
Solution for
Injection 3 ml
Ampoule
25mg Soluie injectabil Administrare
intramuscular
99

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
Diclofenac sodic Arthrotec 50
modified release
tablets
50mg Comprimat cu
eliberare
modificat
Administrare oral
Irlanda Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
Diclofenac sodic Arthrotec 75
modified-release
tablets
75mg Comprimat cu
eliberare
modificat
Administrare oral
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene 25mg
Capsules
25mg Capsul Administrare oral
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene 50mg
Capsules
50mg Capsul Administrare oral
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene 75 mg Dual
Release Capsules
75mg Capsul cu
eliberare dubl
Administrare oral
100

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene 100 mg Dual
Release Capsules
100mg Capsul cu
eliberare dubl
Administrare oral
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene ampoules 75
mg/3 ml Solution for
Injection or
Concentrate for
Solution for Infusion
75mg/3ml Soluie
injectabil/Conce
ntrat pentru
soluie
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Irlanda Astellas Pharma Co. Ltd
5 Waterside
Citywest Busniess Campus
Naas Road
Dublin 24
Ireland
Diclofenac sodic Difene 100mg
Suppositories
100mg Supozitor Administrare
rectal
Irlanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Kyflam 50mg Film
Coated Tablet
50mg Comprimat filmat Administrare oral
Irlanda Morningside Healthcare
Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Diclofenac sodic
Misoprostol
Diclofenac 50
mg/Misoprostol
200 micrograms
modified release
tablets
50mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
101

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Irlanda Morningside Healthcare
Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Diclofenac sodic
Misoprostol
Diclofenac 75
mg/Misoprostol
200 micrograms
modified release
tablets
75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 50mg Comprimat
pentru soluie
oral
Administrare oral
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 50mg Comprimat
gastrorezistent
Administrare oral
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 100mg Supozitor Administrare
rectal
Italia Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac VOLTAREN 75mg/3ml Soluie injectabil Administrare
intramuscular
102

Statul Membru
(UE/SEE)
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Industria Farmaceutica
Galenica Senese S.r.l.
Via Cassia Nord
351 Darvia - 53014 Siena
Italy
Diclofenac sodic ALGOSENAC 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Bayer S.p.a.
Viale Certosa, 130
Milano - 20156
Italy
Diclofenac
hydroxyethylpyrrolid
ine
BAIFENAC 50mg Granule Administrare oral
Italia CostanzaFarma srl
Via Taranto 4
20142 Milano
Italy
Diclofenac sodic DEALGIC 75mg Capsul cu
eliberare
prelungit
Administrare oral
Italia CostanzaFarma srl
Via Taranto 4
20142 Milano
Italy
Diclofenac sodic DEALGIC 100mg Capsul cu
eliberare
prelungit
Administrare oral
Italia DAICHI SANKYO Italia S.p.a.
Via Paolo Di Dono 73
00142, Rome
Italy
Diclofenac sodic DEFLAMAT 25mg/ml Soluie injectabil Administrare
intramuscular
Italia DAICHI SANKYO Italia S.p.a.
Via Paolo Di Dono 73
00142, Rome
Italy
Diclofenac sodic DEFLAMAT 75mg Capsul cu
eliberare
prelungit
Administrare oral
Italia DAICHI SANKYO Italia S.p.a.
Via Paolo Di Dono 73
00142, Rome
Italy
Diclofenac sodic DEFLAMAT 100mg Capsul cu
eliberare
prelungit
Administrare oral
103

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Crinos S.p.a.
Via Pavia, 6
Milano - 20136
Italy
Diclofenac sodic DICLOFAN 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Crinos S.p.a.
Via Pavia, 6
Milano - 20136
Italy
Diclofenac sodic DICLOFAN 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Sandoz S.p.a.
Largo Umberto Boccioni, 1
Origgio, Varese - 21040
Italy
Diclofenac sodic DICLOFENAC 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Sandoz S.p.a.
Largo Umberto Boccioni, 1
Origgio, Varese - 21040
Italy
Diclofenac sodic DICLOFENAC 100mg Supozitor Administrare
rectal
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
50mg Supozitor Administrare
rectal
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
100mg Supozitor Administrare
rectal
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
25mg Comprimat Administrare oral
104

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
50mg Comprimat Administrare oral
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
150mg Capsul cu
eliberare
prelungit
Administrare oral
Italia Alpha Biotech S.r.l.
Via Ragazzi del 99
5, Bologna - 40133
Italy
Diclofenac sodic DICLOFENAC ALPHA
BIOTECH
25mg/ml Picturi orale,
soluie
Administrare oral
Italia Almus S.r.l.
Via Cesarea, 11/10
Genova - 16121
Italy
Diclofenac sodic DICLOFENAC ALMUS 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Angenerico S.p.a.
Via Nocera Umbra 75
Roma - 00181
Italy
Diclofenac sodic DICLOFENAC
ANGENERICO
75mg/3ml Soluie injectabil Administrare
intramuscular
105

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Angenerico S.p.a.
Via Nocera Umbra 75
Roma - 00181
Italy
Diclofenac sodic DICLOFENAC
ANGENERICO
100mg Supozitor Administrare
rectal
Italia Angenerico S.p.a.
Via Nocera Umbra 75
Roma - 00181
Italy
Diclofenac sodic DICLOFENAC
ANGENERICO
50mg Comprimat
gastrorezistent
Administrare oral
Italia Angenerico S.p.a.
Via Nocera Umbra 75
Roma - 00181
Italy
Diclofenac sodic DICLOFENAC
ANGENERICO
25mg Comprimat
gastrorezistent
Administrare oral
Italia Doc Generici S.r.l.
Via Manuzio 7
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC DOC 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Doc Generici S.r.l.
Via Manuzio 7
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC DOC
GENERICI
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Doc Generici S.r.l.
Via Manuzio 7
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC DOC
GENERICI
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia EG S.p.a
Via Scarlatti, 31
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC EG 75mg/3ml Soluie injectabil Administrare
intramuscular
106

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia EG S.p.a
Via Scarlatti, 31
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC EG 50mg Comprimat
gastrorezistent
Administrare oral
Italia EG S.p.a
Via Scarlatti, 31
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC EG 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia EG S.p.a
Via Scarlatti, 31
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC EG 100mg Supozitor Administrare
rectal
Italia Germed Pharma S.p.a.
Via Cantu, 11, Balsamo
Milano, 20092
Italy
Diclofenac sodic DICLOFENAC
GERMED
75mg/3ml Soluie injectabil Administrare
intramuscular
Italia HEXAL S.p.a.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso, 16
Brianza, Milano, 20041
Italy
Diclofenac sodic DICLOFENAC HEXAL 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia HEXAL S.p.a.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso, 16
Brianza, Milano, 20041
Italy
Diclofenac sodic DICLOFENAC HEXAL 100mg Supozitor Administrare
rectal
107

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia HEXAL S.p.a.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso, 16
Brianza, Milano, 20041
Italy
Diclofenac sodic DICLOFENAC HEXAL 50mg Comprimat
gastrorezistent
Administrare oral
Italia HEXAL S.p.a.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso, 16
Brianza, Milano, 20041
Italy
Diclofenac sodic DICLOFENAC HEXAL 25mg Comprimat
gastrorezistent
Administrare oral
Italia Mylan S.p.a.
Via Vittor Pisani, 20
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC MYLAN
GENERICS
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Mylan S.p.a.
Via Vittor Pisani, 20
Milano - 20124
Italy
Diclofenac sodic DICLOFENAC MYLAN
GENERICS
100mg Supozitor Administrare
rectal
Italia Sandoz S.p.a.
Largo Umberto Boccioni, 1
Origgio, Varese - 21040
Italy
Diclofenac sodic DICLOFENAC
SODICO
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Biologici Italia Laboratories
S.r.l.
Via Serpero, 2
Masate, Milano - 20060
Italy
Diclofenac sodic DICLOFENAC
SODICO BIL
75mg/3ml Soluie injectabil Administrare
intramuscular
108

Statul Membru
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 50mg Supozitor Administrare
rectal
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 100mg Supozitor Administrare
rectal
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 150mg Capsul cu
eliberare
prelungit
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 50mg Granule Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 50mg Comprimat
gastrorezistent
Administrare oral
109

Statul Membru
(UE/SEE)
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 25mg/ml Picturi orale,
soluie
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic DICLOREUM 46,5mg/ml Picturi orale,
soluie
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac
hydroxyethylpyrrolid
ine
DIEP 25mg Comprimat
gastrorezistent
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac
hydroxyethylpyrrolid
ine
DIEP 25mg Granule pentru
suspensie oral
Administrare oral
Italia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac potasic EMINOCS 50mg Picturi orale,
soluie
Administrare oral
Italia Proge Farm S.r.l.
Largo Donegani 4/a
Novara - 28100
Italy
Diclofenac sodic FENADOL 100mg Comprimat cu
eliberare
prelungit
Administrare oral
110

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Wellington Street
Development Pharma
Limited
47 Oaklands Drive Rathgar
Dublin 6
Ireland
Diclofenac sodic FENDER 75mg/3ml Soluie injectabil Administrare
intramuscular
Italia Wellington Street
Development Pharma
Limited
47 Oaklands Drive Rathgar
Dublin 6
Ireland
Diclofenac sodic FENDER 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia Bayer S.p.a.
Viale Certosa, 130
Milano - 20156
Italy
Diclofenac
hydroxyethylpyrrolid
ine
FLECTOR DOLORE 25mg Granule pentru
soluie oral
Administrare oral
Italia Menarini Industrie
Farmaceutiche Riunite S.r.l.
Via Sette Santi 3, Firenze
50131- Italy
Diclofenac sodic FLOGOFENAC 100mg Capsul cu
eliberare
prelungit
Administrare oral
Italia FIDIA Farmaceutici S.p.a.
Via Ponte della Fabbrica
3/a, Abano Terme
Padova - 35031
Italy
Diclofenac potasic ITAMIFAST 25mg Comprimat filmat Administrare oral
111

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia FIDIA Farmaceutici S.p.a.
Via Ponte della Fabbrica
3/a, Abano Terme
Padova - 35031
Italy
Diclofenac potasic ITAMIFAST 50mg Comprimat filmat Administrare oral
Italia Scandinavian Regulatory
Services, AB
Svardvagen 3B
Stockholm SE-182 33
Sweden
Diclofenac potasic KAPPADI 25mg Comprimat filmat Administrare oral
Italia Scandinavian Regulatory
Services, AB
Svardvagen 3B
Stockholm SE-182 33
Sweden
Diclofenac potasic KAPPADI 50mg Comprimat filmat Administrare oral
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac sodic NOVAPIRINA 25mg Drajeu Administrare oral
Italia O. P. PHARMA S.r.l.
Via Torino 51
Milano - 20123
Italy
Diclofenac sodic TRAULEN 100mg Comprimat filmat Administrare oral
Italia O. P. PHARMA S.r.l.
Via Torino 51
Milano - 20123
Italy
Diclofenac sodic TRAULEN 75mg/3ml Soluie injectabil Administrare
intramuscular
112

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac sodic VOLTADVANCE 25mg Pulbere pentru
soluie oral
Administrare oral
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac sodic VOLTADVANCE 25mg Comprimat filmat Administrare oral
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac potasic VOLTFAST 50mg Drajeu Administrare oral
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac potasic VOLTFAST 25mg Drajeu Administrare oral
Italia Novartis Pharma S.p.A.
Largo Umberto Boccioni, 1
Origgio - 21040 Varese
Italy
Diclofenac potasic VOLTFAST 50mg Granule pentru
soluie oral
Administrare oral
Italia Altergon Italia S.r.l.
Via Dell'Industria
Pietradefusi - 83030 Avellino
Italy
Diclofenac INFORCE 75mg/ml Soluie injectabil Administrare
intramuscular,
Subcutaneous use
Italia Altergon Italia S.r.l.
Via Dell'Industria
Pietradefusi - 83030 Avellino
Italy
Diclofenac sodic INDICAM 75mg/ml Soluie injectabil Administrare
intramuscular,
Subcutaneous use
113

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Italia Pfizer Italia S.r.l.
Via Isonzo 71
Latina 04100
Italy
Diclofenac sodic
Misoprostol
MISOFENAC 50mg
0,2mg
Comprimat Administrare oral
Italia Pfizer Italia S.r.l.
Via Isonzo 71
Latina 04100
Italy
Diclofenac sodic
Misoprostol
MISOFENAC 75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Italia Pfizer Italia S.r.l.
Via Isonzo 71
Latina 04100
Italy
Diclofenac sodic
Misoprostol
ARTROTEC 50mg
0,2mg
Comprimat Administrare oral
Italia Pfizer Italia S.r.l.
Via Isonzo 71
Latina 04100
Italy
Diclofenac sodic
Misoprostol
ARTROTEC 75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Italia HEXAL AG S.p.a.
Industriestrasse, 25, D-
83607 HOLZKIRCHEN
Germany
Diclofenac sodic DICLOFENAC HEXAL
AG
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Italia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic DICLOFENAC
RATIOPHARM
50mg Comprimat
gastrorezistent
Administrare oral
Italia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic DICLOFENAC
RATIOPHARM
75mg/3ml Soluie injectabil Administrare
intramuscular
114

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Cipla (UK) Ltd
The Old Post House
Heath Road,Weybridge
Surrey KT138TS
United Kingdom
Diclofenac sodic Profenac 75 mg/3 ml
solution for injection
75mg/3ml Soluie injectabil Administrare
intramuscular
Letonia Cipla (UK) Ltd
The Old Post House
Heath Road,Weybridge
Surrey KT138TS
United Kingdom
Diclofenac sodic Profenac SR 100 mg
prolonged-release
tablets
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 50 mg
gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Letonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 25 mg
gastro-resistant
tablets
25mg Comprimat
gastrorezistent
Administrare oral
Letonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm uno 150
mg prolonged-
release tablets
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac-
ratiopharm 75 mg/2
ml solution for
injection
75mg/2ml Soluie injectabil Administrare
intramuscular
115

Statul Membru
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Cipla (UK) Ltd
The Old Post House
Heath Road,Weybridge
Surrey KT138TS
United Kingdom
Diclofenac sodic Diclogen 50 mg
suppositories
50mg Supozitor Administrare
rectal
Letonia Cipla (UK) Ltd
The Old Post House
Heath Road,Weybridge
Surrey KT138TS
United Kingdom
Diclofenac sodic Diclogen 100 mg
suppositories
100mg Supozitor Administrare
rectal
Letonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac sodic Diclac 75 mg/3 ml
solution for
injection/infusion
75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Letonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac sodic Diclac 100 mg
modified release
tablets
100mg Comprimat cu
eliberare
modificat
Administrare oral
Letonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac sodic Diclac ID 75 mg
modified release
tablets
75mg Comprimat cu
eliberare
modificat
Administrare oral
Letonia Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac sodic Diclac ID 150 mg
modified release
tablets
150mg Comprimat cu
eliberare
modificat
Administrare oral
116

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclomelan retard
100 mg sustained-
release tablets
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclomelan 50 mg
gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Letonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic Diclomelan 100 mg
suppositories
100mg Supozitor Administrare
rectal
Letonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac sodic

Tiamina clorhidrat

hydroxyethylpyrrolid
ine

Cianocobalamina
Diclovit hard
capsules
50 mg


50 mg


50 mg


0,25 mg
Capsul Administrare oral
Letonia SIA Briz
Rasas iela 5
Riga, LV-1057
Latvia
Diclofenac sodic Feloran 75 mg/3 ml
solution for injection
75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
117

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic
Clorhidrat de
lidocain
Olfen 75 mg/20
mg/2 ml solution for
injection
75mg/2ml
20mg/2ml
Soluie injectabil Administrare
intramuscular
Letonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen Lactab 50 mg
gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Letonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen Depocaps 100
mg prolonged-
release capsules,
hard
100mg Capsul cu
eliberare
prelungit
Administrare oral
118

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen Rectocaps 100
mg rectal capsules
100mg Capsul moale
rectal
Administrare
rectal
Letonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen Depotabs 75
mg prolonged
release tablets
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 25 mg film-
coated tablets
25mg Comprimat filmat Administrare oral
Letonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 50 mg film-
coated tablets
50mg Comprimat filmat Administrare oral
Letonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 75 mg/3
ml solution for
injection
75mg/3ml Soluie injectabil Administrare
intramuscular
119

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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 100 mg
suppositories
100mg Supozitor Administrare
rectal
Letonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 50 mg
gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Letonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl retard 100
mg prolonged
release capsules
100mg Capsul cu
eliberare
prelungit
Administrare oral
Letonia Pharmaceutical Works
POLPHARMA SA
ul. Pelpliska 19
83-200 Starogard Gdaski
Poland
Diclofenac sodic Majamil retard 100
mg prolonged-
release tablets
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia A/S Olainfarm
Rupnicu iela 5
Olaine, LV 2114
Latvia
Diclofenac potasic Dikloferol 50 mg
coated tablets
50mg Drajeu Administrare oral
Letonia SIA PharmaSwiss Latvia
Gertrudes iela 54 5
Riga, LV 1011
Latvia
Diclofenac sodic Diclorapid 75 mg
gastro-resistant
capsules, hard
75mg Capsul
gastrorezistent
Administrare oral
120

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren 75 mg/3 ml
solution for injection
75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Letonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Voltaren Akti 12,5
mg film-coated
tablets
12,5mg Comprimat filmat Administrare oral
Letonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Voltaren Akti 25 mg
soft capsules
25mg Capsul moale Administrare oral
Letonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac sodic Voltaren Retard 100
mg modified-release
film-coated tablets
100mg Comprimat cu
eliberare
modificat
Administrare oral
Letonia Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac potasic Cataflam 50 mg
film-coated tablets
50mg Comprimat filmat Administrare oral
Letonia GlaxoSmithKline Latvia SIA
Duntes iela 11
Riga LV - 1013
Latvia
Diclofenac sodic Diclofenac 50 mg
suppositories
50mg Supozitor Administrare
rectal
Letonia GlaxoSmithKline Latvia SIA
Duntes iela 11
Riga LV - 1013
Latvia
Diclofenac sodic Diclofenac 100 mg
suppositories
100mg Supozitor Administrare
rectal
121

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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Letonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen SR 100 mg
prolonged-release
tablets
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Letonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen 75 mg/3
ml solution for
injection
75mg/3ml Soluie injectabil Administrare
intramuscular
Letonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen 50 mg
gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Letonia Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral 25 mg/ml
solution for injection
and infusion
25mg/ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Letonia CT Arzneimittel GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Diclofenac sodic Diclo CT 75 mg/2 ml
solution for injection
75mg/2ml Soluie injectabil Administrare
intramuscular
Lituania Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac Diclac 75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
122

Statul Membru
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac Diclac 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Lituania Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac Diclac ID 75mg Comprimat cu
eliberare
modificat
Administrare oral
Lituania Sandoz d.d.
Verovskova 57
SI-1000 Ljubljana
Slovenia
Diclofenac Diclac ID 150mg Comprimat cu
eliberare
modificat
Administrare oral
Lituania UAB PharmaSwiss
eimyniki g. 21B
LT-09200, Vilnius
Lithuania
Diclofenac DicloRapid 75mg Capsul
gastrorezistent
Administrare oral
Lituania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac Dicloberl 75mg/3ml Soluie injectabil Administrare
intramuscular
Lituania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac Dicloberl 50mg Comprimat
gastrorezistent
Administrare oral
123

Statul Membru
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac Dicloberl 100mg Supozitor Administrare
rectal
Lituania UAB BERLIN CHEMIE
MENARINI BALTIC
Jasinskio g. 16 a,
01112 Vilnius
Lithuania
Diclofenac Dicloberl retard 100mg Capsul cu
eliberare
prelungit
Administrare oral
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm
50mg Comprimat
gastrorezistent
Administrare oral
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm
100mg Supozitor Administrare
rectal
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm
50mg Supozitor Administrare
rectal
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm
75mg/2ml Soluie injectabil Administrare
intramuscular
124

Statul Membru
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm
100mg Capsul cu
eliberare
prelungit
Administrare oral
Lituania ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclofenac-
ratiopharm uno
150mg Comprimat cu
eliberare
modificat
Administrare oral
Lituania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac Diclomelan 100mg Supozitor Administrare
rectal
Lituania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac Diclomelan 50mg Comprimat
gastrorezistent
Administrare oral
Lituania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac Diclomelan retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Lituania UAB Corpus Medica
Sukilli pr. 61
LT-49333 Kaunas
Lithuania
Diclofenac FELORAN 75mg/3ml Soluie injectabil Administrare
intramuscular
Lituania Actavis Nordic A/S
rnegrdsvej 16
DK-2820 Gentofte
Denmark
Diclofenac Feloran 100mg Comprimat cu
eliberare
prelungit
Administrare oral
125

Statul Membru
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Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 75mg/3ml Soluie injectabil Administrare
intramuscular
Lituania Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 50mg Comprimat
gastrorezistent
Administrare oral
Lituania Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 50mg Supozitor Administrare
rectal
Lituania Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen SR 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Lituania Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac Olfen Depocaps 100mg Capsul cu
eliberare
prelungit
Administrare oral
126

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac Olfen Depotabs 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Lituania Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac Olfen Lactab 50mg Comprimat
gastrorezistent
Administrare oral
Lituania Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac Olfen Rectocaps 100mg Capsul moale
rectal
Administrare
rectal
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren 75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
127

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren 100mg Supozitor Administrare
rectal
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren Akti 25mg Drajeu Administrare oral
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren Akti 12,5mg Comprimat filmat Administrare oral
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Voltaren Akti 25mg Capsul moale Administrare oral
Lituania Novartis Finland OY
Metsnneidonkuja 10
FIN-02130 Espoo
Finland
Diclofenac Cataflam 50mg Drajeu Administrare oral
Lituania Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 25mg Comprimat filmat Administrare oral
128

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Lituania Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 50mg Comprimat filmat Administrare oral
Lituania Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac
Lidocain
Olfen 75mg/2ml
20mg/2ml
Soluie injectabil Administrare
intramuscular
Lituania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Diclofenac
Tiamina
Piridoxin
Cianocobalamina
Diclovit 50 mg
50 mg
50 mg
0,25 mg
Capsul Administrare oral
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac potasic Cataflam 50mg Drajeu Administrare oral
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac retard 100 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac 75 mg/3 ml
Injektionslsung
75mg Soluie injectabil Administrare
intramuscular
129

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac-100 Zpfchen 100mg Supozitor Administrare
rectal
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac-25 25mg Comprimat
gastrorezistent
Administrare oral
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac-50 50mg Comprimat
gastrorezistent
Administrare oral
Luxemburg Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac sodic Diclac-50 Zpfchen 50mg Supozitor Administrare
rectal
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG-25 25mg Drajeu Administrare oral
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG-50 50mg Drajeu Administrare oral
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG retard
75
75mg Comprimat cu
eliberare
prelungit
Administrare oral
130

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG retard
100
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG 75
mg/3 ml solution
injectable
75mg Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Luxemburg N.V. Eurogenerics S.A
Esplanade Heysel b 22
B-1020 Bruxelles
Belgium
Diclofenac sodic Diclofenac EG 100
suppositoire
100mg Supozitor Administrare
rectal
Luxemburg Mylan bvba
Rozendal Businesspark
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Diclofenac sodic Diclofenac Mylan-75
Retard
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Luxemburg Mylan bvba
Rozendal Businesspark
Terhulpsesteenweg 6A
B-1560 Hoeilaart
Belgium
Diclofenac sodic Diclofenac Mylan-
100 Retard
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Luxemburg ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
Ratiopharm-100
Zpfchen
100mg Supozitor Administrare
rectal
131

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Luxemburg ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
Ratiopharm-25
25mg Comprimat
gastrorezistent
Administrare oral
Luxemburg ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
Ratiopharm-50
50mg Comprimat
gastrorezistent
Administrare oral
Luxemburg ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
Ratiopharm 75 mg/2
ml Injektionslsung
75mg Soluie injectabil Administrare
intramuscular
Luxemburg ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac Retard
Ratiopharm-100
100mg Capsul cu
eliberare
prelungit
Administrare oral
Luxemburg Daiichi Sankyo Belgium SA
Rue Fond Jean Pques 5
B-1348 Louvain-la-Neuve
Belgium
Diclofenac sodic Motifene-75 75mg Capsul cu
eliberare
modificat
Administrare oral
Luxemburg Socobom S.A
Avenue Louise 149 b24
B-1050 Bruxelles
Belgium
Diclofenac sodic Polyflam-50 50mg Comprimat
gastrorezistent
Administrare oral
Luxemburg Socobom S.A
Avenue Louise 149 b24
B-1050 Bruxelles
Belgium
Diclofenac sodic Polyflam-75 75mg Comprimat cu
eliberare
prelungit
Administrare oral
132

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Luxemburg Continental Pharma
Rijksweg, 12
B-2870 Puurs
Belgium
Diclofenac sodic
Misoprostol
Arthrotec-50 50mg
0,2mg
Capsul cu
eliberare
modificat
Administrare oral
Luxemburg Continental Pharma
Rijksweg, 12
B-2870 Puurs
Belgium
Diclofenac sodic
Misoprostol
Arthrotec-75 75mg
0.2mg
Capsul cu
eliberare
modificat
Administrare oral
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren-100
Zpfchen
100mg Supozitor Administrare
rectal
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren-25 25mg Comprimat
gastrorezistent
Administrare oral
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren-50 50mg Comprimat
gastrorezistent
Administrare oral
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren injekt 75mg Soluie injectabil Administrare
intramuscular
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac
Colestiramin
Voltaren resinat 145,6mg Capsul Administrare oral
133

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Luxemburg Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren Retard-100 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Luxemburg Novartis Consumer Health
S.A.
Medialaan, 40
B-1800 Vilvoorde
Belgium
Diclofenac potasic Voltatabs 12,5mg Drajeu Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac potasic Cataflam 25mg Drajeu Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac potasic Cataflam 50mg Drajeu Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac potasic Catafast 50mg Pulbere pentru
soluie oral
Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 12,5mg Supozitor Administrare
rectal
134

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
135

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 50mg Comprimat
pentru dispersie
oral
Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 75mg Comprimat cu
eliberare
modificat
Administrare oral
Malta Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltaren 100mg Comprimat cu
eliberare
modificat
Administrare oral
Malta Proge Farm S.r.l.
Largo Donegani 4/a
Novara - 28100
Italy
Diclofenac sodic Fenadol 100mg Supozitor Administrare
rectal
Malta Proge Farm S.r.l.
Largo Donegani 4/a
Novara - 28100
Italy
Diclofenac sodic Fenadol 100mg Comprimat cu
eliberare
modificat
Administrare oral
Malta Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac potasic Areston 50mg Comprimat filmat Administrare oral
136

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Malta Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral 25mg tablets 25mg Comprimat
gastrorezistent
Administrare oral
Malta Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral 50mg tablets 50mg Comprimat
gastrorezistent
Administrare oral
Malta Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac sodic Almiral injection 75mg/3ml Soluie
injectabil/
perfuzabil
Administrare
intramuscular,
Administrare
intravenoas
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-75 Ampoules 75mg/2ml Soluie injectabil Administrare
intramuscular
137

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-25 Lactab 25mg Comprimat filmat
gastrorezistent
Administrare oral
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-50 Lactab 50mg Comprimat filmat
gastrorezistent
Administrare oral
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-100 Rectocaps 100mg Supozitor Administrare
rectal
138

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-75 SR
Depotabs
75mg Comprimat cu
eliberare
modificat
Administrare oral
Malta Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen-100 SR
Depocaps
100mg Capsul cu
eliberare
modificat
Administrare oral
Malta Remedica Ltd
Limassol Industrial Estate
Aharnon Street
PO Box 51706
CY-3508 Limassol
Cyprus
Diclofenac sodic Remethan 25mg
Tablets
25mg Comprimat
gastrorezistent
Administrare oral
Malta DEMO SA Pharmaceutical
Industry
21st km National Road
Athens-Lamia 14568
Athens
Greece
Diclofenac sodic Urigon 75mg/3ml
solution for injection
75mg/3ml Soluie injectabil Administrare
intramuscular
139

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Norvegia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac potasic Diclofenackalium
Orifarm
25mg Comprimat filmat Administrare oral
Norvegia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac potasic Diclofenackalium
Orifarm
50mg Comprimat filmat Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Voltarol 12,5mg Capsul moale Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Voltarol 25mg Capsul moale Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Voltarol 12,5mg Comprimat filmat Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Voltarol 25mg Drajeu Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Cataflam 12,5mg Drajeu Administrare oral
140

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Cataflam 50mg Drajeu Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac potasic Cataflam 50mg Pulbere pentru
soluie oral
Administrare oral
Norvegia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 25mg Comprimat filmat Administrare oral
Norvegia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 50mg Comprimat filmat Administrare oral
Norvegia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Difenassium 25mg Comprimat filmat Administrare oral
Norvegia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Difenassium 50mg Comprimat filmat Administrare oral
Norvegia Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Diclofenac Actavis 12,5mg Comprimat filmat Administrare oral
141

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Norvegia Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac sodic Modifenac 75mg Capsul cu
eliberare
modificat
Administrare oral
Norvegia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac potasic DiclofenacKalium
ratiopharm
50mg Comprimat filmat Administrare oral
Norvegia Pfizer AS
Lilleakerveien 2B
1324 Lysaker
Norway
Diclofenac sodic
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
Norvegia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
ratiopharm
25mg Comprimat
gastrorezistent
Administrare oral
Norvegia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac sodic Diclofenac
ratiopharm
50mg Comprimat
gastrorezistent
Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
142

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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 25mg/ml Soluie
perfuzabil
/Concentrat
pentru soluie
perfuzabil
Parenteral
Norvegia BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
25mg Comprimat
gastrorezistent
Administrare oral
Norvegia BMM Pharma AB
Blasieholmsgatan 2
SE-111 48 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
50mg Comprimat
gastrorezistent
Administrare oral
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 25mg Supozitor Administrare
rectal
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
Norvegia Novartis Norge AS
Nydalen Alle 37 A
0484 Oslo
Norway
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Polonia Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Vostar 12,5mg Comprimat filmat Administrare oral
143

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic Dicloreum 50mg Comprimat filmat
gastrorezistent
Administrare oral
Polonia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic Dicloreum 25mg/ml Soluie injectabil Administrare
intramuscular
Polonia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac sodic Dicloreum retard 100mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl retard 100mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin
Germany
Diclofenac sodic Dicloberl 50 50mg Supozitor Administrare
rectal
Polonia GlaxoSmithKline
Pharmaceuticals S.A.
Grunwaldzka 189
Pozna 60-322
Poland
Diclofenac sodic Diclofenac GSK 50mg Supozitor Administrare
rectal
144

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia GlaxoSmithKline
Pharmaceuticals S.A.
Grunwaldzka 189
Pozna 60-322
Poland
Diclofenac sodic Diclofenac GSK 100mg Supozitor Administrare
rectal
Polonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen 25mg/ml Soluie injectabil Administrare
intramuscular
Polonia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac sodic Naklofen Duo 75mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen 100 100mg Capsul moale
rectal
Administrare
rectal
145

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen 50 50mg Capsul moale
rectal
Administrare
rectal
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic
Clorhidrat de
lidocain
Olfen 75 37,5mg/ml
10 mg/ml
Soluie injectabil Administrare
intramuscular
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen 100 SR 100mg Capsul cu
eliberare
prelungit
Administrare oral
146

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen 25 25mg Comprimat filmat Administrare oral
Polonia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac sodic Olfen 50 50mg Comprimat filmat Administrare oral
Polonia Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Acti 12,5mg Comprimat filmat Administrare oral
Polonia Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Express 12,5mg Capsul moale Administrare oral
147

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Acti Forte 25mg Comprimat filmat Administrare oral
Polonia Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac potasic Voltaren Express
Forte
25mg Capsul moale Administrare oral
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac potasic Cataflam 50 50mg Comprimat filmat Administrare oral
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren SR 100 100mg Comprimat cu
eliberare
prelungit
Administrare oral
148

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren SR 75 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 25mg Supozitor Administrare
rectal
Polonia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
Polonia Pfizer Europe MA EEIG
Ramsgate Road
Kent, Sandwich CT13 9NJ
United Kingdom
Diclofenac
Misoprostol
Arthrotec Forte 75mg
0.2mg
Comprimat Administrare oral
Polonia Pfizer Europe MA EEIG
Ramsgate Road
Kent, Sandwich CT13 9NJ
United Kingdom
Diclofenac sodic
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat Administrare oral
Polonia PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac sodic DicloDuo 75mg Capsul cu
eliberare
modificat
Administrare oral
149

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Dicloratio Retard
100
100mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Dicloratio 25 25mg Comprimat
gastrorezistent
Administrare oral
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac
Lidocain
Dicloratio 75mg/2ml
20mg/2ml
Soluie injectabil Administrare
intramuscular
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Dicloratio 50 50mg Comprimat
gastrorezistent
Administrare oral
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Olfen UNO 150mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Dicloratio 100 100mg Supozitor Administrare
rectal
Polonia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Dicloratio 50 50mg Supozitor Administrare
rectal
150

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclac 75mg/3ml Soluie injectabil Administrare
intramuscular
Polonia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclac 75 Duo 75mg Comprimat cu
eliberare
modificat
Administrare oral
Polonia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclac 150 Duo 150mg Comprimat cu
eliberare
modificat
Administrare oral
Polonia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclac 100 100mg Supozitor Administrare
rectal
Polonia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diclac 50 50mg Supozitor Administrare
rectal
Polonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 25mg Comprimat filmat Administrare oral
Polonia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 50mg Comprimat filmat Administrare oral
151

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Polonia Warszawskie Zakady
Farmaceutyczne POLFA S.A.
ul. Karolkowa 22/24
Warszawa 01-207
Poland
Diclofenac sodic Difadol 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Polonia Zakady Farmaceutyczne
POLPHARMA S.A.
ul. Pelpliska 19
Starogard Gdaski 83-200
Poland
Diclofenac sodic Majamil
prolongatum
100mg Capsul cu
eliberare
prelungit
Administrare oral
Polonia Zakady Farmaceutyczne
POLPHARMA S.A.
ul. Pelpliska 19
Starogard Gdaski 83-200
Poland
Diclofenac sodic Majamil PPH 25mg Comprimat
gastrorezistent
Administrare oral
Polonia Zakady Farmaceutyczne
POLPHARMA S.A.
ul. Pelpliska 19
Starogard Gdaski 83-200
Poland
Diclofenac sodic Majamil PPH 50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Laboratrios Pfizer, Lda.
Lagoas Park, Edifcio 10
2740-271 Porto Salvo
Portugal
Diclofenac
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat Administrare oral
Portugalia Laboratrios Pfizer, Lda.
Lagoas Park, Edifcio 10
2740-271 Porto Salvo
Portugal
Diclofenac
Misoprostol
Arthrotec 75 75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
152

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Alter, S.A.
Estrada Marco do Grilo -
Zemouto
2830 Coina
Portugal
Diclofenac Diclofenac Alter 50
mg Comprimidos
50mg Drajeu Administrare oral
Portugalia Generis Farmacutica, S.A.
Rua Joo de Deus, 19
2700-487 Amadora
Portugal
Diclofenac Diclofenac Generis
50 mg Comprimidos
Revestidos
50mg Drajeu Administrare oral
Portugalia Labesfal - Laboratrios
Almiro S.A.
Zona Industrial do Lagedo
3465-157 Santiago de
Besteiros
Portugal
Diclofenac Diclofenac Labesfal 100mg Supozitor Administrare
rectal
Portugalia Labesfal - Laboratrios
Almiro S.A.
Zona Industrial do Lagedo
3465-157 Santiago de
Besteiros
Portugal
Diclofenac Diclofenac Labesfal 100mg Capsul cu
eliberare
prelungit
Administrare oral
Portugalia Labesfal - Laboratrios
Almiro S.A.
Zona Industrial do Lagedo
3465-157 Santiago de
Besteiros
Portugal
Diclofenac Diclofenac Labesfal 50mg Comprimat
gastrorezistent
Administrare oral
153

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Labesfal - Laboratrios
Almiro, S.A.
Campo de Besteiros
3465-051 Santiago de
Besteiros
Portugal
Diclofenac Diclofenac Labesfal
75 mg/3ml Soluo
injectvel
75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Portugalia Mylan, Lda.
Rua Doutor Antnio Loureiro
Borges
Edficio Arquiparque 1
R/C Esq
1499-016 Algs
Portugal
Diclofenac Diclofenac Mylan 100mg Capsul cu
eliberare
prelungit
Administrare oral
Portugalia Ratiopharm - Comrcio e
Indstria de Produtos
Farmacuticos, Lda
Rua Quinta do Pinheiro
Edifcio Tejo - 6 Piso
2790-143 Carnaxide
Portugal
Diclofenac Diclofenac
Ratiopharm
50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Ratiopharm - Comrcio e
Indstria de Produtos
Farmacuticos, Lda
Rua Quinta do Pinheiro
Edifcio Tejo - 6 Piso
2790-143 Carnaxide
Portugal
Diclofenac Diclofenac
Ratiopharm 100 mg
Supositrios
100mg Supozitor Administrare
rectal
154

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Ratiopharm - Comrcio e
Indstria de Produtos
Farmacuticos, Lda
Rua Quinta do Pinheiro
Edifcio Tejo - 6 Piso
2790-143 Carnaxide
Portugal
Diclofenac Diclofenac Retard
Ratiopharm
100mg Capsul cu
eliberare
prelungit
Administrare oral
Portugalia Sandoz Farmacutica, Lda.
Alameda da Beloura
Edifcio 1, 2 - Escritrio 15
2710-693 Sintra
Portugal
Diclofenac Diclofenac Sandoz
50 mg Comprimidos
revestidos
50mg Drajeu Administrare oral
Portugalia Labesfal - Laboratrios
Almiro S.A.
Zona Industrial do Lagedo
3465-157 Santiago de
Besteiros
Portugal
Diclofenac Dolacen 75mg/2ml Soluie injectabil Administrare
intramuscular
Portugalia Laboratrio B. A. Farma,
Lda.
Rua Prof. Sousa da Cmara,
207 - 211
1074-803 Lisboa
Portugal
Diclofenac Dorcalor 50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Laboratrios Vitria, S.A.
Rua Elias Garcia, 28 - Venda
Nova
2700-327 Amadora
Portugal
Diclofenac Fenil-V 75mg/2ml Soluie injectabil Administrare
intramuscular
155

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Laboratrios Vitria, S.A.
Rua Elias Garcia, 28 - Venda
Nova
2700-327 Amadora
Portugal
Diclofenac Fenil-V 100mg Supozitor Administrare
rectal
Portugalia Laboratrios Vitria, S.A.
Rua Elias Garcia, 28 - Venda
Nova
2700-327 Amadora
Portugal
Diclofenac Fenil-V 50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Laboratrios Vitria, S.A.
Rua Elias Garcia, 28 - Venda
Nova
2700-327 Amadora
Portugal
Diclofenac Fenil-V Retard 100mg Capsul cu
eliberare
prelungit
Administrare oral
Portugalia Laboratrio Normal -
Produtos Farmacuticos,
Lda.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Flameril 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Portugalia Laboratrio Normal -
Produtos Farmacuticos,
Lda.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Flameril 100mg Supozitor Administrare
rectal
156

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Laboratrio Normal -
Produtos Farmacuticos,
Lda.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Flameril 50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Laboratrio Normal -
Produtos Farmacuticos,
Lda.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Flameril Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Portugalia Mepha Investigao,
Desenvolvimento e
Fabricao Farmacutica,
Lda.
Lagoas Park
Edificio 5-A, Piso 2
2740-298 Porto Salvo
Portugal
Diclofenac Olfen 50mg Comprimat
gastrorezistent
Administrare oral
Portugalia Confar - Consrcio
Farmacutico, Lda.
Rua Flix Correia, 1-B
1500-271 Lisboa
Portugal
Diclofenac Painex 25 25mg Drajeu Administrare oral
157

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Confar - Consrcio
Farmacutico, Lda.
Rua Flix Correia, 1-B
1500-271 Lisboa
Portugal
Diclofenac Painex 50 50mg Drajeu Administrare oral
Portugalia Confar - Consrcio
Farmacutico, Lda.
Rua Flix Correia, 1-B
1500-271 Lisboa
Portugal
Diclofenac Painex R 100mg Capsul cu
eliberare
prelungit
Administrare oral
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren 100mg Supozitor Administrare
rectal
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
158

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren 75 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren Retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Portugalia Laboratrio Normal -
Produtos Farmacuticos,
Lda.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Cataflam 50mg Drajeu Administrare oral
Portugalia Novartis Consumer Health
Produtos Farmacuticos e
Nutrio, Lda.
Rua do Centro Empresarial,
Edf 8, Quinta da Beloura
2710-693 Sintra
Portugal
Diclofenac Otriflu 12,5mg Drajeu Administrare oral
159

Statul Membru
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Novartis Consumer Health
Produtos Farmacuticos e
Nutrio, Lda.
Rua do Centro Empresarial,
Edf 8, Quinta da Beloura
2710-693 Sintra
Portugal
Diclofenac Voltaren 12,5 12,5mg Comprimat filmat Administrare oral
Portugalia Novartis Consumer Health
Produtos Farmacuticos e
Nutrio, Lda.
Rua do Centro Empresarial,
Edf 8, Quinta da Beloura
2710-693 Sintra
Portugal
Diclofenac Voltaren 12,5 12,5mg Capsul moale Administrare oral
Portugalia Novartis Consumer Health
Produtos Farmacuticos e
Nutrio, Lda.
Rua do Centro Empresarial,
Edf 8, Quinta da Beloura
2710-693 Sintra
Portugal
Diclofenac Voltaren 25 25mg Capsul moale Administrare oral
Portugalia Novartis Farma - Produtos
Farmacuticos, S.A.
Rua do Centro Empresarial
Edifcio 8, Quinta da Beloura
2710-444 Sintra
Portugal
Diclofenac Voltaren Rapid 50mg Drajeu Administrare oral
160

Statul Membru
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Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Portugalia Laboratrios Vitria, S.A.
Rua Elias Garcia, 28 - Venda
Nova
2700-327 Amadora
Portugal
Diclofenac Fenil-V Dispersivel 46,5mg Comprimat
pentru dispersie
oral
Administrare oral
Romnia PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac DICLOFENAC DUO
PHARMASWISS 75
mg
75mg Capsul cu
eliberare
prelungit
Administrare oral
Romnia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 150 mg 150mg Capsul cu
eliberare
prelungit
Administrare oral
Romnia Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac TRATUL 50 mg 50mg Capsul moale
gastrorezistent
Administrare oral
Romnia S.C. TERAPIA S.A.
Str. Fabricii nr. 124
Cluj-Napoca 400 632
Romnia
Diclofenac DICLOTARD 100
mg
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Romnia Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac DICLAC 75 ID 75mg Comprimat cu
eliberare
modificat
Administrare oral
161

Statul Membru
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Deintorul autorizaiei
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internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN
RETARD
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Romnia STADA HEMOFARM S.R.L.
Str. Zugrav Nedelcu nr.3,
Timioara
Judeul Timi
Romnia
Diclofenac REFEN RETARD 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Romnia S.C. AC HELCOR PHARMA
SRL
Str. Victor Babe nr. 50
Baia-Mare
Jud. Maramure 430092
Romnia
Diclofenac DICLOFENAC 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Romnia SC ANTIBIOTICE SA
Str. Valea Lupului nr. 1
6600-Iai
Romnia
Diclofenac CLAFEN 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Romnia FARAN LABORATORIES S.A.
17 km Athens-Lamia
Achaias i Trizinas
145 64 Nea Kifisia
Greece
Diclofenac RHEUMAVEK 25mg Comprimat
gastrorezistent
Administrare oral
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN 50 50mg Comprimat
gastrorezistent
Administrare oral
162

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN 25 25mg Comprimat
gastrorezistent
Administrare oral
Romnia S.C. TERAPIA S.A.
Str. Fabricii nr. 124
Cluj-Napoca 400 632
Romnia
Diclofenac DICLOFENAC 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN RAPID 50mg Drajeu Administrare oral
Romnia S.C. ARENA GROUP S.A.
Str. Stefan Mihaileanu
nr.31, sector 2;
Bucuresti
Romnia
Diclofenac DICLOFENAC ARENA
50 mg
25mg Drajeu Administrare oral
Romnia S.C. ARENA GROUP S.A.
Str. Stefan Mihaileanu
nr.31, sector 2;
Bucuresti
Romnia
Diclofenac DICLOFENAC ARENA
50 mg
50mg Drajeu Administrare oral
Romnia S.C. MEDUMAN S.A.
Str. Aleea Eroilor nr. 28
Vieu de Sus
Judeul Maramure 435700
Romnia
Diclofenac N - DICLOFENAC 50mg Drajeu Administrare oral
163

Statul Membru
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Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Romnia ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac DICLOFENAC AL I.M. 75mg/3ml Soluie injectabil Administrare
intramuscular
Romnia Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac TRATUL 30mg/ml Soluie injectabil Administrare
intramuscular
Romnia Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac ALMIRAL 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Romnia S.C. TERAPIA S.A.
Str. Fabricii nr. 124
Cluj-Napoca 400 632
Romnia
Diclofenac DICLOFENAC 75 mg 75mg/3ml Soluie injectabil Administrare
intramuscular
Romnia STADA HEMOFARM S.R.L.
Str. Zugrav Nedelcu nr.3,
Timioara
Judeul Timi
Romnia
Diclofenac REFEN 75 mg 25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
164

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Romnia FARAN LABORATORIES S.A.
17 km Athens-Lamia
Achaias i Trizinas
145 64 Nea Kifisia
Greece
Diclofenac RHEUMAVEK 25mg/ml Soluie injectabil Administrare
intramuscular
Romnia Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac TRATUL 120 mg 120mg Supozitor Administrare
rectal
Romnia Gerot Pharmazeutika GmbH
Arnethgasse 3
A-1160 Vienna
Austria
Diclofenac TRATUL 60 mg 60mg Supozitor Administrare
rectal
Romnia SC ANTIBIOTICE SA
Str. Valea Lupului nr. 1
6600-Iai
Romnia
Diclofenac CLAFEN 100 mg 100mg Supozitor Administrare
rectal
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN 100mg Supozitor Administrare
rectal
Romnia Novartis Pharma GmbH
Roonstrasse 25
Nuernberg D-90429
Germany
Diclofenac VOLTAREN 50mg Supozitor Administrare
rectal
Romnia S.C. MAGISTRA C&C S.R.L.
B-dul Aurel Vlaicu nr. 82A
Constana 900055
Romnia
Diclofenac DICLOFENAC SODIC
100 mg
100mg Supozitor Administrare
rectal
165

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Romnia S.C. MAGISTRA C&C S.R.L.
B-dul Aurel Vlaicu nr. 82A
Constana 900055
Romnia
Diclofenac DICLOFENAC 100
mg
100mg Supozitor Administrare
rectal
Romnia Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac sodic
Orfenadrin citrat
Neodolpasse 75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
intravenoas
Romnia PFIZER EUROPE MA EEIG
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Diclofenac
Misoprostol
ARTHROTEC 75 75mg
0.2mg
Comprimat
gastrorezistent
Administrare oral
Romnia Lannacher Heilmittel
Ges.m.b.H
Schlossplatz 1
8502 Lannach
Austria
Diclofenac sodic

Tiamina clorhidrat

Piridoxin clorhidrat

Cianocobalamina
TRATUL PLUS 50mg

50mg


50mg


0,25mg
Comprimat
gastrorezistent
Administrare oral
Slovacia MEDOPHARM s.r.o.,
Lehrova 1808/11
143 00, Praha 4
Czech Republic
Diclofenac ALMIRAL 75mg/3ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
166

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Medochemie Ltd
1-10 Constantinoupoleos str
P.O. Box 51409
Limassol 3505
Cyprus
Diclofenac ALMIRAL 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia Hexal AG
Industriestrae 25
D-83607 Holzkirchen
Germany
Diclofenac Diclac retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclobene 150 mg
retard
150mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclobene 25 mg 25mg Comprimat
gastrorezistent
Administrare oral
Slovacia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac Diclobene 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac Diclofenac AL 25 25mg Comprimat
gastrorezistent
Administrare oral
167

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
Diclofenac Diclofenac AL 50 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia ALIUD PHARMA GmbH & Co.
KG
Gottlieb Daimler Strasse 19
D-89150 Laichingen
Germany
diclofenac Diclofenac AL retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia PharmaSwiss esk
republika s.r.o.
Jankovcova 1569/2c
170 00 Praha 7 - Holeovice
Czech Republic
Diclofenac Diclofenac Duo
PharmaSwiss 75 mg
75mg Capsul cu
eliberare
modificat
Administrare oral
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 25 mg 25mg Comprimat
gastrorezistent
Administrare oral
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 50 mg 50mg Supozitor Administrare
rectal
168

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 100 mg 100mg Supozitor Administrare
rectal
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM 75 mg 75mg/3ml Soluie injectabil Administrare
intramuscular
Slovacia Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac DICLOREUM retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 25 mg
filmom obalen
tablety
25mg Comprimat filmat Administrare oral
Slovacia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 50 mg
filmom obalen
tablety
50mg Comprimat filmat Administrare oral
Slovacia Zentiva, k.s.
U kabelovny 130
102 37 Praha 10 - Doln
Mcholupy
Czech Republic
Diclofenac Dolmina 50 50mg Comprimat filmat Administrare oral
169

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Zentiva, k.s.
U kabelovny 130
102 37 Praha 10 - Doln
Mcholupy
Czech Republic
Diclofenac DOLMINA INJ 75mg/3ml Soluie injectabil Administrare
intramuscular
Slovacia IBSA Slovakia s.r.o.
Mytna 42
811 05 Bratislava
Slovak Republic
Diclofenac Flector EP Rapid 50
mg
50mg Granule Administrare oral
Slovacia Dr. R. Pfleger Chemische
Fabrik GmbH
Dr.Robert Pfleger Strasse
12
D-96045 Bamberg
Germany
Diclofenac Myogit 50 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 100 mg 100mg Supozitor Administrare
rectal
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 100 retard 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 25 mg 25mg Comprimat
gastrorezistent
Administrare oral
170

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 50 mg 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 75 75mg/3ml Soluie injectabil Administrare
intramuscular
Slovacia Herbacos Recordati s.r.o.
trossova 239
53003 Pardubice
Czech Republic
Diclofenac VERAL 75 retard 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren 100 100mg Supozitor Administrare
rectal
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren 50 50mg Comprimat
gastrorezistent
Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren 75 mg/3 ml 75mg/3ml Soluie injectabil Administrare
intramuscular
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Actigo
Extra 25 mg
25mg Drajeu Administrare oral
171

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Rapid 12,5
mg
12,5mg Capsul moale Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Rapid 25
mg
25mg Capsul moale Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Rapid 50
mg
50mg Drajeu Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Rapid
Sachets
50mg Pulbere pentru
soluie oral
Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren Retard 100 100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia Novartis s.r.o.
Na Pankraci 1724/129
140 00 Praha 4
Czech Republic
Diclofenac Voltaren SR 75 75mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovacia Pfizer Europe MA EEIG
Ramsgate Road
Kent, Sandwich CT13 9NJ
United Kingdom
Diclofenac
Misoprostol
ARTHROTEC FORTE 75mg
0.2mg
Comprimat filmat Administrare oral
172

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovacia Fresenius Kabi Austria GmbH
Hafnerstrasse 36
Graz A-8055
Austria
Diclofenac
Orfenadrin
Neodolpasse 75mg/250ml
30mg/250ml
Soluie
perfuzabil
Administrare
intravenoas
Slovenia PharmaSwiss d.o.o.
Wolfova 1
1000 Ljubljana
Slovenia
Diclofenac Diclo Duo 75 mg
trde
gastrorezistentne
kapsule
75mg Capsul
gastrorezistent
Administrare oral
Slovenia PharmaSwiss d.o.o.
Wolfova 1
1000 Ljubljana
Slovenia
Diclofenac DicloJet 75 mg trde
gastrorezistentne
kapsule
75mg Capsul
gastrorezistent
Administrare oral
Slovenia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 25 mg
filmsko obloene
tablete
25mg Comprimat filmat Administrare oral
Slovenia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac Dicuno 50 mg
filmsko obloene
tablete
50mg Comprimat filmat Administrare oral
Slovenia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 25 mg/ml
raztopina za
injiciranje
25mg/ml Soluie injectabil Administrare
intramuscular
173

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovenia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 50 mg
gastrorezistentne
tablete
50mg Comprimat
gastrorezistent
Administrare oral
Slovenia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen 50 mg
sveke
50mg Supozitor Administrare
rectal
Slovenia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen duo 75 mg
trde kapsule
75mg Capsul Administrare oral
Slovenia Krka, d.d.
Novo mesto
marjeka cesta 6
8501 Novo mesto
Slovenia
Diclofenac Naklofen SR 100 mg
tablete s
podaljanim
sproanjem
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Slovenia Medias International d.o.o.
Leskokova cesta 9D
1000 Ljubljana
Slovenia
Diclofenac Neodolpasse 75
mg/30 mg raztopina
za infundiranje
2,5mg/ml Soluie
perfuzabil
Administrare
intravenoas
Slovenia Pliva Ljubljana d.o.o.
pot k sejmiu 35
1231 Ljubljana rnue
Slovenia
Diclofenac Olfen 100 mg trde
kapsule s
podaljanim
sproanjem
100mg Capsul cu
eliberare
prelungit
Administrare oral
174

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Slovenia Pliva Ljubljana d.o.o.
pot k sejmiu 35
1231 Ljubljana rnue
Slovenia
Diclofenac Voltaren 12,5 mg
sveke
12,5mg Supozitor Administrare
rectal
Slovenia Pliva Ljubljana d.o.o.
pot k sejmiu 35
1231 Ljubljana rnue
Slovenia
Diclofenac Voltaren 25 mg
sveke
25mg Supozitor Administrare
rectal
Slovenia Novartis Consumer Health
GmbH
Zielstattstrasse 40
Munchen 81379
Germany
Diclofenac Voltaren Dolo 12,5
mg filmsko obloene
tablete
12,5mg Comprimat filmat Administrare oral
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic VOLTAREN 100 mg
supositorios
100mg Supozitor Administrare
rectal
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic VOLTAREN 50 mg
comprimidos
gastrorresistentes
50mg Comprimat
gastrorezistent
Administrare oral
175

Statul Membru
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Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic DOLO-VOLTAREN 50
mg comprimidos
dispersables
50mg Comprimat
orodispersabil
Administrare oral
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic VOLTAREN RETARD
75 mg comprimidos
de liberacin
modificada
75mg Comprimat cu
eliberare
modificat
Administrare oral
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic VOLTAREN RETARD
100 mg
comprimidos de
liberacin
modificada
100mg Comprimat cu
eliberare
modificat
Administrare oral
Spania NOVARTIS FARMACEUTICA,
S.A.
Gran Va de les Corts
Catalanes, 764
08013 Barcelona
Spain
Diclofenac sodic VOLTAREN 75 mg/3
ml solucin
inyectable
75mg/3ml Soluie injectabil Administrare
intramuscular
Spania LABORATORIOS ALDO-
UNION, S.A.
Baronesa de Malda, 73
08950 Esplugues de
Llobregat (Barcelona)
Spain
Diclofenac sodic DICLOFENACO
ALDO-UNION
comprimidos EFG
50mg Comprimat Administrare oral
176

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania BEXAL FARMACEUTICA, S.A.
Centro Empresarial Osa
Mayor
Avda. Osa Mayor, 4 - Area B
28023 Aravaca (Madrid)
Spain
Diclofenac sodic DICLOFENACO
BEXAL 50 mg
comprimidos
gastrorresistentes
EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania LABORATORIOS STADA, S.L
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona)
Spain
Diclofenac sodic DICLOFENACO
RETARD STADA 100
mg comprimidos
EFG
100mg Comprimat filmat Administrare oral
Spania LABORATORIOS STADA, S.L
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona)
Spain
Diclofenac sodic DICLOFENACO
STADA 50 mg
comprimidos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania LABORATORIOS NORMON,
S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos (Madrid)
Spain
Diclofenac sodic DICLOFENACO
NORMON 50 mg
comprimidos
dispersables EFG
50mg Comprimat
orodispersabil
Administrare oral
Spania LABORATORIOS NORMON,
S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos (Madrid)
Spain
Diclofenac sodic DICLOFENACO
NORMON 50 mg
comprimidos
entricos EFG
50mg Comprimat
gastrorezistent
Administrare oral
177

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona
(Vizcaya)
Spain
Diclofenac sodic DOLOTREN 50 mg
comprimidos
gastrorresistentes
50mg Comprimat
gastrorezistent
Administrare oral
Spania FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona
(Vizcaya)
Spain
Diclofenac sodic DOLOTREN RETARD
100 mg cpsulas
duras de liberacin
prolongada
100mg Capsul cu
eliberare
modificat
Administrare oral
Spania FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona
(Vizcaya)
Spain
Diclofenac sodic DOLOTREN
DISPERSABLE
comprimidos
50mg Comprimat
orodispersabil
Administrare oral
Spania FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona
(Vizcaya)
Spain
Diclofenac sodic DOLOTREN
supositorios
100mg Supozitor Administrare
rectal
Spania FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona
(Vizcaya)
Spain
Diclofenac sodic DOLOTREN ampollas 75mg/3ml Soluie injectabil Administrare
intramuscular
178

Statul Membru
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania SIGMA TAU ESPAA, S.A.
Bolivia, 15
Polgono Industrial Azque
28806 Alcal de Henares
(Madrid)
Spain
Diclofenac sodic LUASE 50 mg
comprimidos
50mg Comprimat
gastrorezistent
Administrare oral
Spania LABORATORIOS LLORENS,
S.A.
Ciudad de Balaguer, 7-11
08022 Barcelona
Spain
Diclofenac sodic DICLOFENACO
LLORENS 50 mg
comprimidos
entricos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania LABORATORIOS LLORENS,
S.A.
Ciudad de Balaguer, 7-11
08022 Barcelona
Spain
Diclofenac sodic DICLOFENACO
LLORENS 75 mg
solucin inyectable
EFG
75mg/3ml Soluie injectabil Administrare
intramuscular
Spania LABORATORIOS LLORENS,
S.A.
Ciudad de Balaguer, 7-11
08022 Barcelona
Spain
Diclofenac sodic DI-RETARD 100 mg
comprimidos de
liberacin
modificada
100mg Comprimat cu
eliberare
modificat
Administrare oral
Spania LABORATORIOS LLORENS,
S.A.
Ciudad de Balaguer, 7-11
08022 Barcelona
Spain
Diclofenac sodic DICLOFENACO
LLORENS 100 mg
supositorios EFG
100mg Supozitor Administrare
rectal
179

Statul Membru
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Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania RATIOPHARM ESPAA, S.A.
Avda. de Burgos, 16 D
5 planta
28036 Madrid
Spain
Diclofenac sodic DICLOFENACO
RATIOPHARM 50 mg
comprimidos
50mg Drajeu Administrare oral
Spania LABORATORIOS ALTER, S.A.
Mateo Inurria, 30
28036 Madrid
Spain
Diclofenac sodic DICLOFENACO
ALTER 50 mg
comprimidos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania PENSA PHARMA, S.A.U.
Jorge Comn (mdico
pediatra), 3-bajos
46015 Valencia
Spain
Diclofenac sodic DICLOFENACO
PENSA 50 mg
comprimidos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania LABORATORIOS CINFA, S.A.
Olaz-Chipi, 10
Polgono Industrial Areta
31620 Huarte-Pamplona
(Navarra)
Spain
Diclofenac sodic DICLOFENACO
CINFA 50 mg
comprimidos
gastrorresistentes
EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania SANDOZ FARMACEUTICA,
S.A.
Avda. Osa Mayor, 4
28023 Aravaca (Madrid)
Spain
Diclofenac sodic DICLOFENACO
SANDOZ 50 mg
comprimidos
gastrorresistentes
EFG
50mg Comprimat
gastrorezistent
Administrare oral
180

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania SANDOZ FARMACEUTICA,
S.A.
Avda. Osa Mayor, 4
28023 Aravaca (Madrid)
Spain
Diclofenac sodic DICLOFENACO
SANDOZ 100 mg
supositorios EFG
100mg Supozitor Administrare
rectal
Spania SANDOZ FARMACEUTICA,
S.A.
Avda. Osa Mayor, 4
28023 Aravaca (Madrid)
Spain
Diclofenac sodic DICLOFENACO
SANDOZ RETARD
100 mg
comprimidos de
liberacin
modificada EFG
100mg Comprimat cu
eliberare
modificat
Administrare oral
Spania LABORATORIOS RANBAXY,
S.L.
Passeig de Gracia, 9
08007 Barcelona
Spain
Diclofenac sodic DICLOFENACO
MUNDOGEN 50 mg
comprimidos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania GERMED FARMACEUTICA,
S.L.
Chile, 8-2 planta. Oficina
203
28290 Las Matas (Madrid)
Spain
Diclofenac sodic DICLOFENACO
EDIGEN 50 mg
comprimidos EFG
50mg Comprimat
gastrorezistent
Administrare oral
Spania Pfizer S.L.
Avda. de Europa, 20 B
Parque Empresarial La
Moraleja
28108 Alcobendas (Madrid)
Spain
Diclofenac sodic
Misoprostol
ARTROTEC 50mg
0,2mg
Comprimat filmat Administrare oral
181

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Spania Pfizer S.L.
Avda. de Europa, 20 B
Parque Empresarial La
Moraleja
28108 Alcobendas (Madrid)
Spain
Diclofenac sodic
Misoprostol
NORMULEN 50mg
0,2mg
Comprimat filmat Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 25mg Comprimat
gastrorezistent
Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 50mg Comprimat
gastrorezistent
Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac potasic Voltaren T 12,5mg Comprimat filmat Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 25mg/ml Soluie injectabil Parenteral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac potasic Voltaren T 25mg Drajeu Administrare oral
182

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac potasic Voltaren T 50mg Drajeu Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac potasic Voltaren T 12,5mg Capsul moale Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac potasic Voltaren T 25mg Capsul moale Administrare oral
Suedia Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac sodic Diklofenak Mylan 25mg Comprimat
gastrorezistent
Administrare oral
Suedia Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac sodic Diklofenak Mylan 50mg Comprimat
gastrorezistent
Administrare oral
Suedia Pfizer AB
Vetenskapsvgen 10
191 90 Sollentuna
Sweden
Diclofenac
Misoprostol
Arthrotec 50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
183

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Pfizer AB
Vetenskapsvgen 10
191 90 Sollentuna
Sweden
Diclofenac sodic
Misoprostol
Arthrotec forte 75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Suedia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diklofenak Sandoz 25mg Comprimat
gastrorezistent
Administrare oral
Suedia Sandoz GmbH
Biochemiestrae 10
Kundl A-6250
Austria
Diclofenac sodic Diklofenak Sandoz 50mg Comprimat
gastrorezistent
Administrare oral
Suedia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac potasic Diclofenac T
ratiopharm
25mg Comprimat filmat Administrare oral
Suedia ratiopharm GmbH
Graf Arco Strasse 3
D-89079 Ulm
Germany
Diclofenac potasic Diclofenac T
ratiopharm
50mg Comprimat filmat Administrare oral
Suedia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac sodic Diklofenak Orifarm 25mg Comprimat
gastrorezistent
Administrare oral
Suedia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac sodic Diklofenak Orifarm 50mg Comprimat
gastrorezistent
Administrare oral
184

Statul Membru
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac potasic Eeze 25mg Comprimat filmat Administrare oral
Suedia Evolan Pharma AB
Box: 120
182 12 Danderyd
Sweden
Diclofenac potasic Diklofenak T Evolan 50mg Comprimat filmat Administrare oral
Suedia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac sodic Diklofenak T Orifarm 25mg Comprimat filmat Administrare oral
Suedia Orifarm Generics A/S
PO 69, Energivej 15
DK-5260 Odense S
Denmark
Diclofenac sodic Diklofenak T Orifarm 50mg Comprimat filmat Administrare oral
Suedia Actavis A/S
Ornegardsvej 16
2820 Gentofte
Denmark
Diclofenac potasic Diklofenak T Actavis 25mg Comprimat filmat Administrare oral
Suedia Actavis A/S
Ornegardsvej 16
2820 Gentofte
Denmark
Diclofenac potasic Diklofenak T Actavis 50mg Comprimat filmat Administrare oral
Suedia Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
25mg Comprimat
gastrorezistent
Administrare oral
185

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac sodic Diclofenac BMM
Pharma
50mg Comprimat
gastrorezistent
Administrare oral
Suedia Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Diclofenac potasic Instantin 50mg Pulbere pentru
soluie oral
Administrare oral
Suedia Meda OTC AB
stermalmsgatan 19
11426 Stockholm
Sweden
Diclofenac potasic Eezeneo 25mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Eezeneo 50mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Eeze 12,5mg Comprimat filmat Administrare oral
Suedia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 25mg Comprimat filmat Administrare oral
Suedia Vitabalans OY
Varastokatu 8
FI-135 000 Hmeenlinna
Finland
Diclofenac potasic Dicuno 50mg Comprimat filmat Administrare oral
186

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Diklotab 25mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Diklotab 50mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Diklok 25mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Diklok 50mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Kappadi 25mg Comprimat filmat Administrare oral
Suedia Mimer Medical
Svrdvgen 3B
SE-182 33 Danderyd
Sweden
Diclofenac potasic Kappadi 50mg Comprimat filmat Administrare oral
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 100mg Supozitor Administrare
rectal
187

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 50mg Supozitor Administrare
rectal
Suedia Novartis Sverige AB
Box 1150
183 11 Tby
Sweden
Diclofenac sodic Voltaren 25mg Supozitor Administrare
rectal
Suedia Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac sodic Diklofenak Mylan 100mg Supozitor Administrare
rectal
Suedia Mylan AB
PO 230 33
Ynglingagatan 14
SE-104 35 Stockholm
Sweden
Diclofenac sodic Diklofenak Mylan 50mg Supozitor Administrare
rectal
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis 25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis 50 mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
188

Statul Membru
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Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis Retard 75
mg, tabletten met
gereguleerde afgifte
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis Retard 100
mg, tabletten met
gereguleerde afgifte
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis 25 mg,
zetpillen
25mg Supozitor Administrare
rectal
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis 50 mg,
zetpillen
50mg Supozitor Administrare
rectal
Olanda Actavis B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands
Diclofenac sodic Diclofenacnatrium
Actavis 100 mg,
zetpillen
100mg Supozitor Administrare
rectal
Olanda Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Diclofenac Kalium
Actavis 12,5 mg,
filmomhulde
tabletten
12,5mg Comprimat filmat Administrare oral
Olanda Alfa Wassermann S.p.A.
Via Enrico Fermi 1
Alanno (PE) 65020
Italy
Diclofenac potasic Eminocs 50 mg/ml,
drank
50mg Picturi orale,
soluie
Administrare oral
189

Statul Membru
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Deintorul autorizaiei
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Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex 25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex 50 mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex retard 100
mg, tabletten met
gereguleerde afgifte
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex 25 mg,
zetpillen
25mg Supozitor Administrare
rectal
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex 50 mg,
zetpillen
50mg Supozitor Administrare
rectal
Olanda Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
The Netherlands
Diclofenac sodic Diclofenacnatrium
Apotex 100 mg,
zetpillen
100mg Supozitor Administrare
rectal
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na CF 25
mg/ml, oplossing
voor injectie
25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
190

Statul Membru
(UE/SEE)
Deintorul autorizaiei
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Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na CF 25
mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na CF 50
mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na zetpil
CF 50 mg, zetpillen
50mg Supozitor Administrare
rectal
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na zetpil
CF 100 mg, zetpillen
100mg Supozitor Administrare
rectal
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na retard
CF 75 mg, tabletten
met gereguleerde
afgifte
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Centrafarm B.V.
Nieuwe Donk 3
4879 AC Etten Leur
The Netherlands
Diclofenac sodic Diclofenac Na retard
CF 100 mg,
tabletten met
gereguleerde afgifte
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar EC 25,
maagsapresistente
tabletten 25 mg
25mg Comprimat
gastrorezistent
Administrare oral
191

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar EC 50,
maagsapresistente
tabletten 50 mg
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar Retard 75,
tabletten met
gereguleerde afgifte
75 mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar Retard 100,
tabletten met
gereguleerde afgifte
100 mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar 25, zetpillen
25 mg
25mg Supozitor Administrare
rectal
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar 50, zetpillen
50 mg
50mg Supozitor Administrare
rectal
Olanda Disphar International B.V.
Winkelskamp 6
7255 PZ Hengelo
The Netherlands
Diclofenac sodic Diclofenacnatrium
Disphar 100,
zetpillen 100 mg
100mg Supozitor Administrare
rectal
192

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Manston Pharma Limited
3 Montpelier Avenue, Bexley
DA5 3AP Kent
United Kingdom
Diclofenac sodic Diclofenacnatrium
Manston 25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Manston Pharma Limited
3 Montpelier Avenue, Bexley
DA5 3AP Kent
United Kingdom
Diclofenac sodic Diclofenacnatrium
Manston 50 mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Manston Pharma Limited
3 Montpelier Avenue, Bexley
DA5 3AP Kent
United Kingdom
Diclofenac sodic Diclofenacnatrium
retard Manston 100
mg,
maagsapresistente
tabletten
100mg Comprimat
gastrorezistent
Administrare oral
Olanda Marel B.V.
Archimedesweg 2
2333 CN Leiden
The Netherlands
Diclofenac potasic Kruidvat Diclofenac
kalium 12,5 mg,
filmomhulde
tabletten
12,5mg Comprimat filmat Administrare oral
Olanda Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands
Diclofenac sodic Diclofenacnatrium
50 mg, zetpillen
50mg Supozitor Administrare
rectal
Olanda Mylan B.V.
Dieselweg 25
3752 LB Bunschoten
The Netherlands
Diclofenac sodic Diclofenacnatrium
100 mg, zetpillen
100mg Supozitor Administrare
rectal
193

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Novartis Consumer Health
B.V.
Claudius Prinselaan 142
4818 CP Breda
The Netherlands
Diclofenac potasic Voltaren K 12,5 mg,
filmomhulde
tabletten
12,5mg Comprimat filmat Administrare oral
Olanda Novartis Consumer Health
B.V.
Claudius Prinselaan 142
4818 CP Breda
The Netherlands
Diclofenac potasic Voltaren K 25 mg,
omhulde tabletten
25mg Drajeu Administrare oral
Olanda Novartis Consumer Health
B.V.
Claudius Prinselaan 142
4818 CP Breda
The Netherlands
Diclofenac potasic Otriflu, omhulde
tabletten 12,5 mg
12,5mg Drajeu Administrare oral
Olanda Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands
Diclofenac sodic Voltaren 25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands
Diclofenac sodic Voltaren 75 mg/3
ml, oplossing voor
injectie 25 mg/ml
25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Olanda Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands
Diclofenac potasic Cataflam 50,
omhulde tabletten
50 mg
50mg Drajeu Administrare oral
194

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Novartis Pharma B.V.
Raapopseweg 1
6824 DP Arnhem
The Netherlands
Diclofenac sodic Voltaren Retard 75
mg, tabletten met
verlengde afgifte
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Olanda Pfizer B.V.
Rivium Westlaan 142
2909 LD Capelle aan den
IJssel
The Netherlands
Diclofenac sodic
Misoprostol
Arthrotec 50,
tabletten
50mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Pfizer B.V.
Rivium Westlaan 142
2909 LD Capelle aan den
IJssel
The Netherlands
Diclofenac sodic
Misoprostol
Arthrotec 75,
tabletten 75 mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
25 PCH,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
50 PCH,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
25 PCH, zetpillen 25
mg
25mg Supozitor Administrare
rectal
195

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
50 PCH, zetpillen 50
mg
50mg Supozitor Administrare
rectal
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
100 PCH, zetpillen
100 mg
100mg Supozitor Administrare
rectal
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenac Na retard
75 PCH, tabletten
met gereguleerde
afgifte 75 mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenac Na Retard
100 PCH tabletten
met gereguleerde
afgifte 100 mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Pharmacin B.V.
Molenvliet 103
3335 LH Zwijndrecht
The Netherlands
Diclofenac sodic Diclofenacnatrium
Pharmacin 25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Pharmacin B.V.
Molenvliet 103
3335 LH Zwijndrecht
The Netherlands
Diclofenac sodic Diclofenacnatrium
Pharmacin 50 mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Pharmacin B.V.
Molenvliet 103
3335 LH Zwijndrecht
The Netherlands
Diclofenac sodic Diclofenac Na
Pharmacin 100 mg,
tabletten met
gereguleerde afgifte
100mg Comprimat cu
eliberare
modificat
Administrare oral
196

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda ratiopharm Nederland B.V.
Florapark 4
2012 HK Haarlem
The Netherlands
Diclofenac sodic Diclofenac Na
ratiopharm retard 75
mg, tabletten met
gereguleerde afgifte
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Diclofenac sodic Diclofenacnatrium
Sandoz retard 75,
tabletten met
gereguleerde afgite
75 mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Diclofenac sodic Diclofenacnatrium
Sandoz retard 100,
tabletten met
gereguleerde afgite
100 mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Olanda Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Diclofenac sodic Diclofenacnatrium
Sandoz 25,
maagsapresistente
tabletten 25 mg
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Diclofenac sodic Diclofenacnatrium
Sandoz 50,
maagsapresistente
tabletten 50 mg
50mg Comprimat
gastrorezistent
Administrare oral
Olanda Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands
Diclofenac sodic Diclofenacnatrium
Sandoz injectie 75
mg/3 ml, oplossing
voor injectie 25
mg/ml
25mg/ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
197

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Olanda Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
25 mg Teva, zetpilen
25mg Supozitor Administrare
rectal
Olanda Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
50 mg Teva, zetpilen
50mg Supozitor Administrare
rectal
Olanda Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Diclofenac sodic Diclofenacnatrium
100 mg Teva,
zetpilen
100mg Supozitor Administrare
rectal
Olanda Wise Pharmaceuticals Ltd.
Hamwells Business Park Unit
No. 7, Hardicker Street
M19 2RB Manchester
United Kingdom
Diclofenac sodic Diclofenacnatrium
25 mg,
maagsapresistente
tabletten
25mg Comprimat
gastrorezistent
Administrare oral
Olanda Wise Pharmaceuticals Ltd.
Hamwells Business Park Unit
No. 7, Hardicker Street
M19 2RB Manchester
United Kingdom
Diclofenac sodic Diclofenacnatrium
50 mg,
maagsapresistente
tabletten
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Novartis Consumer Health
UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom
Diclofenac potasic Voltarol Pain-Eze
Extra Strength
Tablets
25mg Drajeu Administrare oral
198

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Novartis Consumer Health
UK Limited
Park View, Riverside Way
Watchmoor Park, Camberley
Surrey GU15 3YL
United Kingdom
Diclofenac potasic Voltarol Pain-Eze
Tablets
12,5mg Drajeu Administrare oral
Marea Britanie Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Diclofenac sodic Arthrotec 50
Modified-Release
tablets
50mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Diclofenac sodic Arthrotec 75
Modified-Release
tablets
75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Injection
75mg/3ml
75mg Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac Voltarol Dispersible
Tablets 50mg
46,5mg Comprimat
pentru soluie
oral
Administrare oral
199

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Retard
Tablets 100mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol SR Tablets 75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol
Suppositories
12.5mg
12,5mg Supozitor Administrare
rectal
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol
Suppositories 25mg
25mg Supozitor Administrare
rectal
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol
Suppositories 50mg
50mg Supozitor Administrare
rectal
200

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol
Suppositories
100mg
100mg Supozitor Administrare
rectal
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Tablets
25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Tablets
50mg
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Rapid
Tablets 25mg
25mg Drajeu Administrare oral
Marea Britanie Novartis Pharmaceuticals UK
ltd.
Frimley, Camberley
Surrey GU16 7SR
United Kingdom
Diclofenac sodic Voltarol Rapid
Tablets 50mg
50mg Drajeu Administrare oral
201

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Actavis UK Limited
Whiddon Valley
Barnstaple
North Devon EX32 8NS
United Kingdom
Diclofenac sodic Flamatak MR Tablets
75mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
E Sussex BN22 9AG
United Kingdom
Diclofenac sodic Teva UK Diclofenac
sodium Tablets
25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Teva UK Limited
Brampton Road
Hampden Park
Eastbourne
E Sussex BN22 9AG
United Kingdom
Diclofenac sodic Teva UK Diclofenac
sodium Tablets
50mg
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Chatfield Pharmaceuticals
Limited
Kramer Mews
London SW5 9JL
United Kingdom
Diclofenac sodic Chatfield Pharms
Diclofenac Sodium
Tablets 25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Mercury Pharma
International Limited
4045 Kingswood Road
City West Business Park
Co Dublin, Ireland
Diclofenac sodic Antigen Diclofenac
Sodium Injection
2.5% w/v
75mg Soluie injectabil Administrare
intramuscular
202

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Sandoz Ltd
Rhumalgan CR75
Modified Release
Tablets 75mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Sandoz Ltd
Rhumalgan CR100
Modified Release
Tablet 100mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Lagap Pharms
Diclofenac Tablets
25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Lagap Pharms
Diclofenac Tablets
50mg
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Sandoz Ltd Diclovol
SR Modified Release
Tablet 75 mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
203

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Sandoz Ltd
Rhumalgan SR
Modified Release
Capsules 75mg
75mg Capsul cu
eliberare
modificat
Administrare oral
Marea Britanie Sandoz Limited
Frimley Business Park
Frimley
Camberley, GUI16 7SR
United Kingdom
Diclofenac sodic Sandoz Ltd
Rhumalgan XL
Modified Release
Capsules 100mg
100mg Capsul cu
eliberare
modificat
Administrare oral
Marea Britanie Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom
Diclofenac sodic Generics UK
Diclofenac sodium
Tablets 25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Generics (UK) Limited
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom
Diclofenac sodic Generics UK
Diclofenac Sodium
Tablets 50mg
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Waymade Plc
Regency House
Miles Gray Road
Basildon, Essex SS14 3RF
United Kingdom
Diclofenac sodic Rheumatac Retard
Tablets 75mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
204

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Daichi-Sankyo UK Limited
Chiltern Place
Chalfont Park
Gerrards Cross
Buckinghamshire SL9 0BG
United Kingdom
Diclofenac sodic Motifene Capsules
75mg
75mg Capsul cu
eliberare
modificat
Administrare oral
Marea Britanie Chiesi Limited
Cheadle Royal Business Park
Highfield, Cheadle
Cheshire SK8 3GY
United Kingdom
Diclofenac sodic Volsaid Retard
Tablets 75mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Chiesi Limited
Cheadle Royal Business Park
Highfield, Cheadle
Cheshire SK8 3GY
United Kingdom
Diclofenac sodic Volsaid Retard
Tablets 100mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Econac
Suppositories
100mg
100mg Supozitor Administrare
rectal
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Econac Injection
75mg/3ml
75mg Soluie injectabil Administrare
intramuscular
205

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Mercury Pharms
Diclofenac Solution
for Injection
75mg/3ml
75mg Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Mercury Pharms
Econac SR Prolonged
Release Tablet 75mg
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Mercury Pharms
Econac XL Prolonged
Release Tablet
100mg
100mg Comprimat cu
eliberare
prelungit
Administrare oral
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Mercury Pharms
Diclofenac Sodium
Tablets 25mg
25mg Comprimat Administrare oral
Marea Britanie Mercury Pharma Group
Limited
No. 1 Croydon
12-16 Addiscombe Road
Croydon, Surrey CR0 0XT
United Kingdom
Diclofenac sodic Mercury Pharms
Diclofenac Sodium
Tablets 75mg
50mg Comprimat Administrare oral
206

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Co-Pharma Limited
Unit 4, Metro Centre
Tolpits Lane, Watford
Hertfordshire WD18 9SS
United Kingdom
Diclofenac sodic Diclo-XL 100 100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Co-Pharma Limited
Unit 4, Metro Centre
Tolpits Lane, Watford
Hertfordshire WD18 9SS
United Kingdom
Diclofenac sodic Diclo-SR 75 75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Dexcel Pharma Limited
7 Sopwith Way
Drayton Fields
Industrial Estate, Daventry
Northamptonshire NN11 8PB
United Kingdom
Diclofenac sodic Dexcel-Pharma
Dicloflex Retard
Prolonged Release
Tablet 100mg
100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Dexcel Pharma Limited
7 Sopwith Way
Drayton Fields
Industrial Estate, Daventry
Northamptonshire NN11 8PB
United Kingdom
Diclofenac sodic Dexcel-Pharma
Dicloflex SR
Prolonged Release
Tablet 75mg
75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Dexcel Pharma Limited
7 Sopwith Way
Drayton Fields
Industrial Estate, Daventry
Northamptonshire NN11 8PB
United Kingdom
Diclofenac sodic Dexcel-Pharma
Diclofenac Sodium
Tablets 25mg
25mg Comprimat
gastrorezistent
Administrare oral
207

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Dexcel Pharma Limited
7 Sopwith Way
Drayton Fields
Industrial Estate, Daventry
Northamptonshire NN11 8PB
United Kingdom
Diclofenac sodic Dexcel-Pharma
Diclofenac Sodium
Tablets 75mg
75mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Bristol Laboratories Limited
Unit 3, Canal side
Northbridge
Road,Berkhamsted
Hertfordshire HP4 1EG
United Kingdom
Diclofenac sodic Volraman 25mg
Gastro-resistant
tablets
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Bristol Laboratories Limited
Unit 3, Canal side
Northbridge
Road,Berkhamsted
Hertfordshire HP4 1EG
United Kingdom
Diclofenac sodic Volraman 50mg
Gastro-resistant
tablets
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Focus Pharmaceuticals
Limited
Unit 5, Faraday court
First Avenue,Centrum 100
Burton upon trent
Staffordshire, DE14 2WX
United Kingdom
Diclofenac potasic Adacium Rapid
50mg Tablets
50mg Comprimat filmat Administrare oral
Marea Britanie Morningside Healthcare
Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Diclofenac sodic
Misoprostol
Misofen
50mg/200mcg
modified released
tablets
50mg
0,2mg
Comprimat cu
eliberare
modificat
Administrare oral
208

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Morningside Healthcare
Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom
Diclofenac sodic
Misoprostol
Misofen
75mg/200mcg
modified released
tablets
75mg
0.2mg
Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Crescent Pharma Limited
Unit 3&4
Quidhampton Business Units
Polhampton Lane, Overton
Hampshire, RG25 3ED
United Kingdom
Diclofenac Crescent Pharma
Diclofenac Tablets
BP 25mg
25mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Crescent Pharma Limited
Unit 3&4
Quidhampton Business Units
Polhampton Lane, Overton
Hampshire, RG25 3ED
United Kingdom
Diclofenac Crescent Pharma
Diclofenac Tablets
BP 50mg
50mg Comprimat
gastrorezistent
Administrare oral
Marea Britanie Therabel pharma UK Limited
Compass House, vision Park
Chivers, Histon
Cambridge CB24 9AD
United Kingdom
Diclofenac sodic Dyloject 75mg/2ml
solution for injection
75mg/2ml Soluie injectabil Administrare
intramuscular,
Administrare
intravenoas
Marea Britanie Galen Limited
Seagoe Industrial Estate
Craigavon
Armagh BT 63 5AU
United Kingdom
Diclofenac sodic Diclomax SR 75mg Capsul cu
eliberare
modificat
Administrare oral
209

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Galen Limited
Seagoe Industrial Estate
Craigavon
Armagh BT 63 5AU
United Kingdom
Diclofenac sodic Diclomax Retard 100mg Capsul cu
eliberare
modificat
Administrare oral
Marea Britanie Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Doble action pain
relief
12,5mg Comprimat Administrare oral
Marea Britanie Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Diclofenac
potassium 12.5mg
Tablets
12,5mg Comprimat Administrare oral
Marea Britanie Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Diclofenac
potassium 25mg
Tablets
25mg Comprimat filmat Administrare oral
Marea Britanie Actavis Group PTC ehf
Reykjavikurvegi 76-78
IS-220 Hafnarfjrdur
Iceand
Diclofenac potasic Diclofenac
potassium 50mg
Tablets
50mg Comprimat filmat Administrare oral
Marea Britanie Chelonia Healthcare Limited
Boumpoulinas 11
3rd, Nicosia
CY-1060
Cyprus
Diclofenac sodic Diclofenac sodium
25mg Tablets
25mg Comprimat
gastrorezistent
Administrare oral
210

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie RI Pharma Limited
First floor,6 St John's Court
Upper Fforest Way
Swansea Enterprise Park
Swansea SA6 8QQ
United Kingdom
Diclofenac sodic Slofenac 75mg SR 75mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie RI Pharma Limited
First floor,6 St John's Court
Upper Fforest Way
Swansea Enterprise Park
Swansea SA6 8QQ
United Kingdom
Diclofenac sodic Slofenac 100mg SR 100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Ennogen Pharma Limited
Unit G4, Riverside Way
Dartford, DA1 5BS
United Kingdom
Diclofenac sodic Enstar SR 75mg
Tablets
75mg Comprimat cu
eliberare
prelungit
Administrare oral
Marea Britanie Ennogen Pharma Limited
Unit G4, Riverside Way
Dartford, DA1 5BS
United Kingdom
Diclofenac sodic Enstar XL 100mg
Tablets
100mg Comprimat cu
eliberare
modificat
Administrare oral
Marea Britanie Aptil Pharma limited
9th Floor
CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom
Diclofenac potasic Diclofenac
potassium 12.5mg
Tablets
12,5mg Comprimat filmat Administrare oral
211

Statul Membru
(UE/SEE)
Deintorul autorizaiei
de punere pe pia
Denumire comun
internaional
Numele inventat Concentraia Forma
farmaceutic
Calea de
administrare
Marea Britanie Aptil Pharma limited
9th Floor
CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom
Diclofenac potasic Diclofenac
potassium 25mg
Tablets
25mg Comprimat filmat Administrare oral
Marea Britanie Aptil Pharma limited
9th Floor
CP House
97-107 Uxbridge Road
London W5 5TL
United Kingdom
Diclofenac potasic Diclofenac
potassium 50mg
Tablets
50mg Comprimat filmat Administrare oral