INN Invented name Strengths Pharmaceutical forms. Arthrotec forte - Manteltabletten. Arthrotec - Manteltabletten. Kapseln. Kapseln.

Transcription

1 Annex I List of the names, pharmaceutical, strengths of the medicinal products, routes of, marketing authorisation s in the Member States 1

2 Pfizer Corporation Ges.m.b.H Floridsdorfer Hauptstraße 1, 1210 Vienna Misoprostol Arthrotec forte - Mantelten 75mg 0.2mg Coated Pfizer Corporation Ges.m.b.H Floridsdorfer Hauptstraße 1, 1210 Vienna Misoprostol Arthrotec - Mantelten 50mg 0,2mg Coated Astellas Pharma GmbH Linzer Straße 221/E Vienna Dedolor akut 75 mg Kapseln 75mg Gastro-resistant capsule, hard Astellas Pharma GmbH Linzer Straße 221/E Vienna Dedolor DRS 100 mg Kapseln 100mg Capsule, hard Astellas Pharma GmbH Linzer Straße 221/E Vienna Deflamat DRS 75 mg Kapseln 75mg Capsule, hard Astellas Pharma GmbH Linzer Straße 221/E Vienna Deflamat 75 mg - Ampullen 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use 2

3 Astellas Pharma GmbH Linzer Straße 221/E Vienna Deflamat 50 mg Kapseln 50mg Capsule, hard Astellas Pharma GmbH Linzer Straße 221/E Vienna Deflamat 100 mg Suppositorien 100mg Suppository Rectal use Astellas Pharma GmbH Linzer Straße 221/E Vienna Deflamat retard 100 mg Kapseln 100mg Capsule, hard Hexal Pharma GmbH Stella-Klein-Löw-Weg Vienna DiclacHexal 50 mg - Filmten 50mg Film-coated Hexal Pharma GmbH Stella-Klein-Löw-Weg Vienna DiclacHexal rapid 50 mg - lösbare Tabletten 50mg Soluble Hexal Pharma GmbH Stella-Klein-Löw-Weg Vienna DiclacHexal retard 150 mg - Tabletten 150mg Prolonged-release Hexal Pharma GmbH Stella-Klein-Löw-Weg Vienna DiclacHexal retard 75 mg - Tabletten 75mg Prolonged-release 3

4 ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene 75 mg Ampullen 75mg/2ml Solution for /infusion Intramuscular use, Intravenous use ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene 25 mg Filmten 25mg Film-coated ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene 50 mg Filmten 50mg Film-coated ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene 100 mg Zäpfchen 100mg Suppository Rectal use ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene 50 mg Zäpfchen 50mg Suppository Rectal use 4

5 ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene retard 100 mg - Kapseln 100mg Capsule, hard ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclobene uno 150 mg - Retardten 150mg Prolonged-release 1A Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac akut 1A Pharma 50 mg - lösbare Tabletten 50mg Soluble Genericon Pharma Gesellschaft m.b.h. Hafnerstraße Graz Diclofenac Genericon 75 mg - Ampullen 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use Genericon Pharma Gesellschaft m.b.h. Hafnerstraße Graz Diclofenac "Genericon" 50 mg - Filmten 50mg Film-coated 5

6 Genericon Pharma Gesellschaft m.b.h. Hafnerstraße Graz Diclofenac Genericon retard 100 mg Filmten 100mg Film-coated S.MED Handels GmbH Zachgasse Vienna DICLOFENAC "S.Med" 25 mg- Filmten 25mg Film-coated S.MED Handels GmbH Zachgasse Vienna DICLOFENAC "S.Med" 50 mg - Filmten 50mg Film-coated S.MED Handels GmbH Zachgasse Vienna Diclofenac S.Med 75 mg/3 ml - Ampullen 75mg/3ml Solution for Intramuscular use S.MED Handels GmbH Zachgasse Vienna DICLOFENAC "S.Med" retard 100 mg - Tabletten 100mg Tablet S.MED Handels GmbH Zachgasse Vienna DICLOFENAC "S.Med" retard 75 mg - Tabletten 75mg Tablet 6

7 G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac G.L. 50 mg - Filmten 50mg Film-coated 1A Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac 1A Pharma retard 150 mg - Tabletten 150mg Prolonged-release 1A Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac 1A Pharma retard 75 mg - Tabletten 75mg Prolonged-release G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac G.L. retard 100 mg - Filmten 100mg Film-coated Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Diclofenac Sandoz 75 mg Ampullen 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Diclofenac Sandoz 50 mg Filmten 50mg Film-coated Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Diclofenac Sandoz 150 mg - Retardten 150mg Prolonged-release 7

8 Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Lannacher Heilmittel Ges.m.b.H Schlossplatz Lannach Lannacher Heilmittel Ges.m.b.H Schlossplatz Lannach STADA Arzneimittel GmbH Muthgasse Vienna STADA Arzneimittel GmbH Muthgasse Vienna STADA Arzneimittel GmbH Muthgasse Vienna Diclofenac Sandoz 75 mg - Retardten 75mg Prolonged-release Diclofenac "Sandoz" 100mg Film-coated retard 100 mg Filmten Diclo-B Lannacher - 50mg Capsule, hard Kapseln Diclo-B G.L. 50mg Capsule, hard Diclostad Ampullen 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use Diclofenac Sodium Diclostad 50 mg 50mg Film-coated Filmten Diclostad retard mg Film-coated mg Filmten 8

9 G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 MERCK GesmbH Zimbagasse Vienna Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclovit-Kapseln 50mg Capsule, hard Dolpasse 75 mg 75mg/250ml Solution for Intravenous use Infusionslösung Infusion Dolpasse retard mg Film-coated mg - Filmten Neodolpasse 75mg/250ml Solution for Intravenous use Orphenadrine citrate Infusionslösung 30mg/250ml Infusion Neurofenac - 50mg Capsule, hard Kapseln Tratul retard 100 mg 100mg Film-coated - Filmten Voltaren 25 mg - 25mg Film-coated Filmten 9

10 Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren 50 mg - Filmten 50mg Film-coated Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren 75mg/3ml - Injektionslösung 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren 25 mg - Zäpfchen 25mg Suppository Rectal use Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren 100 mg - Zäpfchen für Erwachsene 100mg Suppository Rectal use Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren 50 mg - Zäpfchen für Erwachsene 50mg Suppository Rectal use Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Voltaren retard 100 mg - Filmten 100mg Film-coated Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Diclofenac Acid Tratul 50 mg - Kapseln 50mg Gastro-resistant capsule, soft 10

11 Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac Acid Voltaren dispers - lösliche Tabletten 46,5mg Soluble ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse Vienna Diclofenac potassium Diclobene rapid 50 mg Filmten 50mg Film-coated Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac potassium Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen 50mg Powder for oral solution Novartis Pharma GmbH Stella-Klein-Löw-Weg Vienna Diclofenac potassium Voltaren rapid 50 mg - Dragees 50mg Coated Belgium Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium Misoprostol ARTHROTEC 50 50mg 0,2mg Modified-release Belgium Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium Misoprostol ARTHROTEC 75 75mg 0.2mg Modified-release 11

12 Belgium Belgium Belgium Belgium Belgium Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5, box Jette Belgium APOTEX NV Av. du Bourg. Etienne Demunter 5, box Jette Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac potassium CATAFLAM 50 MG 50mg Coated Diclofenac potassium CATAFLAM 50 MG 50mg Powder for oral solution Diclofenac CATAFLAM 46,5mg Dispersible DISPERSIBLE DICLOFENAC 100mg Prolonged-release APOTEX 100 MG DICLOFENAC 75mg Prolonged-release APOTEX 75 MG DICLOFENAC EG mg Suppository Rectal use MG 12

13 Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium DICLOFENAC EG 25MG 25mg Coated Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium DICLOFENAC EG 50 MG 50mg Coated Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium DICLOFENAC EG 75 MG 75mg/3ml Solution for Intramuscular use Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium DICLOFENAC EG RETARD 100 MG 100mg Prolonged-release Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium DICLOFENAC EG RETARD 75 MG 75mg Prolonged-release Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium DICLOFENAC RETARD MYLAN 100MG 100mg Prolonged-release 13

14 Belgium Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium DICLOFENAC RETARD MYLAN 75MG 75mg Prolonged-release Belgium SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde Belgium DICLOFENAC SANDOZ 50 MG 50mg Gastro-resistant Belgium SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde Belgium DICLOFENAC SANDOZ 75 MG 75mg/3ml Solution for Intramuscular use, Intravenous use Belgium SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde Belgium DICLOFENAC SANDOZ RETARD 100 MG 100mg Modified-release Belgium SANDOZ N.V. Telecom Gardens Medialaan Vilvoorde Belgium DICLOFENAC SANDOZ RETARD 75 MG 75mg Modified-release 14

15 Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium DICLOFENAC TEVA mg Suppository Rectal use Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium DICLOFENAC TEVA 100 MG RETARD 100mg Prolonged-release Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium DICLOFENAC TEVA 50 MG 50mg Gastro-resistant Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium DICLOFENAC TEVA 75 MG / 3 ML 75mg/3ml Solution for Intramuscular use Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium DICLOFENAC TEVA 75 MG RETARD 75mg Prolonged-release Belgium Teva Pharma Belgium N.V. Laarstraat Wilrijk Belgium Diclofenac potassium DICLOFENAC-K- TEVA 50 MG COMPR 50mg Film-coated Belgium RATIOPHARM BELGIUM S.A. Rue Saint-Lambert Woluwé-saint-lambert Belgium DICLOFENAC- RATIOPHARM 50 MG GASTRO- 50mg Gastro-resistant 15

16 Belgium Belgium Belgium Belgium Belgium Belgium LABORATORIA QUALIPHAR N.V/S.A Rijksweg Bornem Belgium SOCOBOM N.V. Louizalaan 149 box Ixelles Belgium Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 B-1348 Louvain-la-Neuve Belgium SOCOBOM N.V. Louizalaan 149 box Ixelles Belgium SOCOBOM N.V. Louizalaan 149 box Ixelles Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium DICLOFENACUM NATRI QUALIPHAR 50 MG 50mg Gastro-resistant FLAMPHAR 50 MG 50mg Tablet MOTIFENE 75MG 75mg Modified-release capsule POLYFLAM 75 MG 75mg Prolonged-release POLYFLAM EX 50mg Coated RUFIMAX EX ALGIRHUMA 50 MG VOLTAREN mg Suppository Rectal use 16

17 Belgium Belgium Belgium Belgium Belgium Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium NOVARTIS PHARMA N.V. Medialaan, 40, box Vilvoorde Belgium Novartis Consumer Health S.A. Medialaan, 40 B-1800 Vilvoorde Belgium VOLTAREN 25 25mg Gastro-resistant VOLTAREN 50 50mg Gastro-resistant VOLTAREN 75 MG/3 75mg/3ml Solution for Intramuscular use ML VOLTAREN RETARD 100mg Tablet 100 VOLTAREN RETARD 75mg Tablet 75 MG Diclofenac potassium VOLTATABS 12,5 12,5mg Coated MG(EX:ZYMAMED) 17

18 Bulgaria Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Almiral 50mg Gastro-resistant Bulgaria Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Almiral 75mg/3ml Solution for Intramuscular use, Intravenous use Bulgaria PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 - Holešovice Czech Republic Diclofenac Duo 75mg Prolonged-release capsule, hard Bulgaria Tchaikapharma Highquality Medicines 1 G. M. Dimitrov Blvd. Sofia 1172 Bulgaria Diclofenac- Tchaikapharma 50mg Gastro-resistant Bulgaria Hexal AG Industriestraße 25 D Holzkirchen Diclac 75mg/3ml Solution for Intramuscular use, Intravenous use Bulgaria Hexal AG Industriestraße 25 D Holzkirchen Diclac 75mg Modified-release 18

19 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Hexal AG Industriestraße 25 D Holzkirchen Sopharma Pharmaceuticals 5 Lachezar Stanchev Str. Sofia 1220 Bulgaria Actavis EAD 29 Atanas Dukov Str. Sofia 1407 Bulgaria Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclac 150mg Modified-release Feloran 100mg Suppository Rectal use Feloran Actavis 100mg Prolonged-release Naklofen SR 100mg Prolonged-release Naklofen DUO 75mg Modified-release capsule, hard Naklofen 75mg/3ml Solution for Intramuscular use 19

20 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Naklofen 50mg Gastro-resistant Neodolpasse 75mg/250ml Solution for Intravenous use Orphenadrine citrate 30mg/250ml infusion Voltaren 25mg Gastro-resistant Voltaren 100mg Suppository Rectal use Voltaren 50mg Suppository Rectal use Diclofenac potassium Voltfast 50mg Powder for oral solution 20

21 Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Bulgaria Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Sopharma Pharmaceuticals 5 Lachezar Stanchev Str. Sofia 1220 Bulgaria Voltaren 50mg Gastro-resistant Voltaren Retard 100mg Prolonged-release Voltaren 75mg/3ml Solution for Intramuscular use, Intravenous use Diclofenac potassium Voltaren Dolo 12,5mg Capsule, soft Diclofenac potassium Voltaren Dolo 12,5mg Film-coated Feloran 25mg/ml solution for Intramuscular use, Intravenous use 21

22 Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ALMIRAL INJECTION 75MG/3ML 75mg/3ml Injection Intramuscular use Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ALMIRAL SUPPOSITORY 100MG 100mg Suppository Rectal use Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ALMIRAL SUPPOSITORY 50MG 50mg Suppository Rectal use Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ALMIRAL GASTRO- RESISTANT TABLET 25MG 25mg Tablet Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ALMIRAL GASTRO- RESISTANT TABLET 50MG 50mg Tablet 22

23 Cyprus Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus ARESTON TABLET 50MG 50mg Tablet Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Diclofenac potassium CATAFLAM ORAL DROPS 1.5% 15mg/ml Oral drops, solution Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Diclofenac potassium CATAFLAM COATED TABLET 50MG 50mg Tablet Cyprus P.T.Hadjigeorgiou CO ltd, P.O.Box Lemesos Cyprus DICLAC INJECTION 75MG/3ML 75mg/3ml Injection Intramuscular use Cyprus Hexal AG Industriestraße 25 D Holzkirchen DICLAC 50 HEXAL GASTRO-RESISTANT TABLET 50MG 50mg Tablet Cyprus Hexal AG Industriestraße 25 D Holzkirchen DICLAC 75 ID HEXAL SUSTAINED RELEASE TABLET 75MG 75mg Tablet 23

24 Cyprus Medlink Pharmaceuticals ltd 30 Armenias Str. P.O.Box Strovolos Cyprus DIFENE DUAL CAPSULE 100MG 100mg Capsule Cyprus Medlink Pharmaceuticals ltd 30 Armenias Str. P.O.Box Strovolos Cyprus DIFENE DUAL CAPSULE 75MG 75mg Capsule Cyprus Interpak ltd Aharnon st Industrial Estate P.O. Box Lemesos Cyprus NERITAN GASTRO RESISTANT TABLET 50MG 50mg Tablet Cyprus Interpak ltd Aharnon st Industrial Estate P.O. Box Lemesos Cyprus NERITAN GASTRO RESISTANT TABLET 25MG 25mg Tablet Cyprus Remedica ltd Aharnon str. P.O. Box Lemesos Cyprus REMETHAN SUPPOSITORY 100MG 100mg Suppository Rectal use 24

25 Cyprus Remedica ltd Aharnon str. P.O. Box Lemesos Cyprus REMETHAN SUSTAINED RELEASE TABLET 100MG 100mg Tablet Cyprus Remedica ltd Aharnon str. P.O. Box Lemesos Cyprus REMETHAN GASTRO RESISTANT TABLET 25MG 25mg Tablet Cyprus Remedica ltd Aharnon str. P.O. Box Lemesos Cyprus REMETHAN GASTRO RESISTANT TABLET 50MG 50mg Tablet Cyprus Codal Synto ltd 33 Theklas Lysioti str. P.O. Box Lemesos Cyprus TAKS INJECTION 75MG/3ML 75mg/3ml Injection Intramuscular use Cyprus Codal Synto ltd 33 Theklas Lysioti str. P.O. Box Lemesos Cyprus TAKS GASTRO RESISTANT TABLET 50MG 50mg Tablet 25

26 Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR VOLTAREN INJECTION 75MG/3ML 75mg/3ml Injection Intramuscular use Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR VOLTAREN SUPPOSITORY 100MG 100mg Suppository Rectal use Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR VOLTAREN SUPPOSITORY 50MG 50mg Suppository Rectal use Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR VOLTAREN GASTRO RESISTANT TABLET 50MG 50mg Tablet Cyprus Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR VOLTAREN D DISPERSIBLE TABLET 50MG 50mg Tablet 26

27 Cyprus Cyprus Cyprus Cyprus Czech Republic Novartis Hellas S.A.C.I. 12th km National Road No1 Metamorfosi Attiki Athens Greece Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus VOLTAREN DOLO FILM COATED TABLET 12.5MG 12,5mg Tablet VOLTAREN FOR 12,5mg Suppository Rectal use CHILDREN SUPPOSITORY 12.5MG VOLTAREN RETARD 100mg Tablet SUSTAINED RELEASE TABLET 100MG VOLTAREN SR 75mg Tablet SUSTAINED RELEASE TABLET 75MG Diclofenacum natricum ALMIRAL 25mg/ml Solution for Intramuscular use, Intravenous use 27

28 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Apotex Europe B.V. Darwinweg CR Leiden Apotex Europe B.V. Darwinweg CR Leiden Apotex Europe B.V. Darwinweg CR Leiden ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenacum natricum ALMIRAL 50 50mg Gastro-resistant Diclofenacum natricum APO-DICLO SR mg Modified-release Diclofenacum natricum APO-DICLO 25 MG 25mg Gastro-resistant Diclofenacum natricum APO-DICLO 50 MG 50mg Gastro-resistant Diclofenacum natricum DICLOFENAC AL 100mg Prolonged-release RETARD Diclofenacum natricum DICLOFENAC AL 25 25mg Film-coated 28

29 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 - Holešovice Czech Republic Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenacum natricum DICLOFENAC AL 50 50mg Film-coated Diclofenacum natricum DICLOFENAC DUO 75mg Modified-release PHARMASWISS 75 capsule, hard MG Diclofenacum natricum DICLOREUM 25mg/ml Solution for Intramuscular use Diclofenacum natricum DICLOREUM RETARD 100mg Prolonged-release Diclofenacum natricum DICLOREUM mg Suppository Rectal use Diclofenacum natricum DICLOREUM 50 50mg Suppository Rectal use 29

30 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Zentiva, k.s. U kabelovny Praha 10 - Dolní Měcholupy Czech Republic Zentiva, k.s. U kabelovny Praha 10 - Dolní Měcholupy Czech Republic Zentiva, k.s. U kabelovny Praha 10 - Dolní Měcholupy Czech Republic Diclofenacum natricum DICLOREUM 50 50mg Gastro-resistant Diclofenac potassium DICUNO 25 MG 25mg Film-coated POTAHOVANÉ TABLETY Diclofenac potassium DICUNO 50 MG 50mg Film-coated POTAHOVANÉ TABLETY Diclofenacum natricum DOLMINA INJ 25mg/ml Solution for Intramuscular use, Intravenous use Diclofenacum natricum DOLMINA 100 SR 100mg Prolonged-release Diclofenacum natricum DOLMINA 50 50mg Film-coated 30

31 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic IBSA Slovakia s.r.o. Mytna Bratislava Slovak Republic Winthrop Arzneimittel GmbH Industriestrasse 26 Mülheim-Kärlich Winthrop Arzneimittel GmbH Industriestrasse 26 Mülheim-Kärlich Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenacum epolaminum FLECTOR EP RAPID 50 MG 50mg Granules for oral solution Diclofenacum natricum MONOFLAM 100 MG 100mg Suppository Rectal use Diclofenacum natricum MONOFLAM 50 MG 50mg Gastro-resistant Diclofenacum natricum MYOGIT 25 25mg Gastro-resistant Diclofenacum natricum MYOGIT 50 50mg Gastro-resistant Diclofenacum natricum NAKLOFEN DUO 75mg Modified-release TOBOLKY capsule, hard 31

32 Czech Republic Czech Republic Czech Republic Czech Republic Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Orphenadrine citrate Neodolpasse 75mg/250ml 30mg/250ml Solution for infusion Intravenous use Diclofenacum natricum OLFEN-100 SR 100mg Prolonged-release capsule, hard Diclofenacum natricum OLFEN-50 50mg Film-coated Diclofenacum natricum OLFEN mg/ml Solution for Intramuscular use 32

33 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic ratiopharm GmbH Graf Arco Strasse 3 D Ulm Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Diclofenacum natricum UNO 150mg Prolonged-release Diclofenacum natricum VERAL 100 MG 100mg Suppository Rectal use Diclofenacum natricum VERAL 100 RETARD 100mg Modified-release Diclofenacum natricum VERAL 25 MG 25mg Gastro-resistant Diclofenacum natricum VERAL 50 MG 50mg Gastro-resistant Diclofenacum natricum VERAL 75 25mg/ml Solution for Intramuscular use, Intravenous use Diclofenacum natricum VERAL 75 RETARD 75mg Modified-release 33

34 Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic Diclofenacum natricum VOLTAREN 25mg/ml Solution for Intramuscular use, Intravenous use Diclofenacum natricum VOLTAREN RETARD 100mg Prolonged-release Diclofenacum natricum VOLTAREN 50 50mg Gastro-resistant Diclofenac potassium VOLTAREN RAPID 50 50mg Coated MG TABLETY Diclofenac potassium VOLTAREN ACTIGO 12,5mg Film-coated Diclofenac potassium VOLTAREN ACTIGO 25mg Coated EXTRA Diclofenac potassium VOLTAREN RAPID 12,5mg Capsule, soft 12,5 MG 34

35 Czech Republic Denmark Denmark Denmark Denmark Denmark Novartis s.r.o. Na Pankráci 1724/ Praha 4 - Nusle Czech Republic PharmaCoDane ApS Marielundvej 46 A DK-2730 Herlev Denmark PharmaCoDane ApS Marielundvej 46 A DK-2730 Herlev Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Købenahvn S Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Købenahvn S Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 Købenahvn S Denmark Diclofenac potassium VOLTAREN RAPID 25 MG 25mg Capsule, soft Diclofenac Diclodan 50mg Suppository Rectal use Diclofenac Diclodan 100mg Suppository Rectal use Diclofenac Diclon 100mg Suppository Rectal use Diclofenac Diclon Rapid 50mg Film-coated Diclofenac Diclon Rapid 25mg Film-coated 35

36 Denmark Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Diclofenac Diklofenak "Mylan" 50mg Gastro-resistant Denmark Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac Diklofenak "Orifarm" 25mg Gastro-resistant Denmark Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac Diklofenak "Orifarm" 50mg Gastro-resistant Denmark Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenac Modifenac 75mg Modified-release capsule Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Diclofenac Voltaren 25mg Gastro-resistant Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Diclofenac Voltaren 50mg Gastro-resistant 36

37 Denmark Denmark Denmark Denmark Denmark Denmark Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Diclofenac Voltaren 100mg Suppository Rectal use Diclofenac Voltaren 25mg/ml Solution for Intramuscular use Diclofenac Voltaren 50mg Suppository Rectal use Diclofenac Voltaren Dolo 12,5mg Film-coated Diclofenac Voltaren Dolo 12,5mg Capsule, soft Diclofenac Voltaren Dolo 12,5mg Tablet Diclofenac Voltaren Rapid 50mg Tablet 37

38 Denmark Denmark Denmark Denmark Denmark Denmark Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 København Ø Denmark BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac Voltaren Retard 100mg Prolonged-release Diclofenac Voltaren Retard 75mg Prolonged-release Diclofenac Diclofenac "BMM 50mg Gastro-resistant Pharma" Diclofenac Diclofenac "BMM 25mg Gastro-resistant Pharma" Diclofenac Diclofenac Rapid 50mg Film-coated "Actavis" Diclofenac Diclofenac Rapid 25mg Film-coated "Actavis" Diclofenac Diclofenac Rapid 50mg Film-coated "Orifarm" 38

39 Denmark Denmark Denmark Denmark Denmark Denmark Denmark Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Teva Denmark A/S Parallelvej DK-2800 Kongens Lyngby Denmark Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenac Diclofenac Rapid "Orifarm" 25mg Film-coated Diclofenac Diclofenac Rapid 50mg Film-coated "Teva" Diclofenac Diclon 50mg Gastro-resistant Diclofenac Diclon 100mg Prolonged-release Diclofenac Diclon 75mg Prolonged-release Diclofenac Diclon 25mg Gastro-resistant Diclofenac Diclopax 25mg Film-coated 39

40 Denmark Denmark Denmark Denmark Denmark Denmark Denmark Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Meda OTC AB Östermalmsgatan Stockholm Sweden Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac Diclopax 50mg Film-coated Diclofenac Diklotab 25mg Film-coated Diclofenac Diklotab 50mg Film-coated Diclofenac Eeze 25mg Film-coated Diclofenac Fenacta 12,5mg Film-coated Diclofenac Dicuno 50mg Film-coated Diclofenac Dicuno 25mg Film-coated 40

41 Denmark Denmark Estonia Estonia Estonia Estonia Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac Misoprostol Arthrotec 50mg 0,2mg Tablet Diclofenac Arthrotec Forte 75mg Tablet Misoprostol 0.2mg Diclofenac DICLOBERL 25mg/ml Solution for Intramuscular use 75MG/3ML Diclofenac DICLOBERL RETARD 100mg Prolonged-release capsule, hard Diclofenac DICLOMELAN 50 MG 50mg Gastro-resistant Diclofenac DICLOMELAN 100mg Suppository Rectal use 41

42 Estonia Estonia Estonia Estonia Estonia G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac DICLOMELAN RETARD 100 MG 100mg Prolonged-release Diclofenac NAKLOFEN 50mg Gastro-resistant Diclofenac NAKLOFEN 50mg Suppository Rectal use Diclofenac NAKLOFEN 25mg/ml Solution for Intramuscular use Diclofenac NAKLOFEN SR 100mg Prolonged-release 42

43 Estonia Estonia Estonia Estonia Estonia Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenac ALMIRAL 25mg/ml Solution for Intramuscular use, Intravenous use Diclofenac OLFEN DEPOCAPS 100mg Prolonged-release capsule, hard Diclofenac OLFEN DEPOCAPS 75mg Prolonged-release Diclofenac CATAFLAM 50mg Coated Diclofenac VOLTAREN 25mg/ml Solution for Intramuscular use 43

44 Estonia Estonia Estonia Estonia Estonia Estonia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Pfizer Enterprises SARL Round-Point du Kirchberg 51, Avenue J.F.Kennedy L-1855 Luxembourg Luxembourg Pharmaswiss Eesti OÜ Tammsaare tee Tallinn Estonia ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac VOLTAREN RETARD 100mg Prolonged-release Diclofenac VOLTAREN AKTI 12,5mg Film-coated Diclofenac ARTHROTEC 50mg Modified-release Misoprostol 0,2mg Diclofenac DICLORAPID 75mg Gastro-resistant capsule, hard Diclofenac DICLOFENAC- 50mg Gastro-resistant RATIOPHARM 50MG Diclofenac DICLOFENAC- 50mg Suppository Rectal use RATIOPHARM 50MG 44

45 Estonia Estonia Estonia Estonia Estonia Estonia Estonia ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenac DICLOFENAC- RATIOPHARM 100 MG 100mg Suppository Rectal use Diclofenac DICLOFENAC- 75mg/2ml Solution for Intramuscular use RATIOPHARM 75MG/2ML Diclofenac DICLOFENAC- 150mg Modified-release RATIOPHARM UNO Diclofenac DICLAC mg Suppository Rectal use Diclofenac DICLAC 25mg/ml Solution for Intramuscular use Diclofenac DICLAC ID 75 MG 75mg Modified-release Diclofenac DICLAC ID 150 MG 150mg Modified-release 45

46 Estonia Estonia Estonia Finland Finland Finland Finland Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark ratiopharm Oy P.O.Box Espoo Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac DICLAC 100 MG 100mg Prolonged-release Diclofenac DICUNO 25mg Film-coated Diclofenac DICUNO 50mg Film-coated Diclofenacum kalium Diclofenac Rapid 50mg Film-coated oral use Orifarm Diclofenacum kalium Diclomex Rapid 50mg Film-coated oral use Diclofenacum kalium Dicuno 25mg Film-coated oral use Diclofenacum kalium Dicuno 50mg Film-coated oral use 46

47 Finland Finland Finland Finland Finland Finland Finland Meda OTC AB Östermalmsgatan Stockholm Sweden Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Pfizer Oy Tietokuja Helsinki Finland Pfizer Oy Tietokuja Helsinki Finland BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden Diclofenacum kalium Eeze 25mg Film-coated oral use Diclofenacum kalium Voltaren Rapid 25mg Coated oral use Diclofenacum kalium Voltaren Rapid 50mg Coated oral use Diclofenacum kalium Voltfast 50mg Powder for oral oral use solution Diclofenacum natricum Arthrotec 50mg Tablet oral use Misoprostolum 0,2mg Diclofenacum natricum Arthrotec Forte 75mg Prolonged-release oral use Misoprostolum 0.2mg Diclofenacum natricum Diclofenac BMM 25mg Gastro-resistant oral use Pharma 47

48 Finland Finland Finland Finland Finland Finland BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Oy Stada Pharma Ab P.O.Box Helsinki Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Diclofenac BMM Pharma 50mg Gastro-resistant oral use Diclofenacum natricum Diclomex 25mg Gastro-resistant oral use Diclofenacum natricum Diclomex 50mg Gastro-resistant oral use Diclofenacum natricum Motifene Dual 75mg Prolonged-release oral use capsule Diclofenacum natricum Voltaren 100mg Suppository rectal use Diclofenacum natricum Voltaren 25mg Gastro-resistant oral use 48

49 Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren 25mg/ml Solution for /concentrate for solution for infusion Intramuscular use, Intravenous use Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren 50mg Gastro-resistant oral use Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren Retard 100mg Prolonged-release oral use Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren Retard 75mg Prolonged-release oral use France Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis Antibes France Diclofenac epolamine FLECTOR 25 mg, granulés pour solution buvable en sachet-dose 25mg Granules for oral solution 49

50 France Laboratoires Genevrier 280, rue de Goa Les Trois Moulins - Parc de Sophia Antipolis Antibes France Diclofenac epolamine FLECTOR 50 mg, granulés pour solution buvable en sachet-dose 50mg Granules for oral solution France Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenac potassium DICLOFENAC ACTAVIS 12,5 mg, comprimé pelliculé 12,5mg Film-coated France NOVARTIS SANTE FAMILIALE 14, boulevard Richelieu Rueil-Malmaison France Diclofenac potassium VOLTARENDOLO 12,5 mg, comprimé enrobé 12,5mg Coated France ARROW GENERIQUES 26, avenue Tony Garnier Lyon France DICLOFENAC ARROW 50 mg, comprimé gastrorésistant 50mg Gastro-resistant France BIOGARAN 15, boulevard Charles de Gaulle Colombes France DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant 50mg Film-coated gastro-resistant France SANDOZ 49, avenue Georges Pompidou Levallois-Perret France DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant 50mg Gastro-resistant 50

51 France CRISTERS 22 quai Gallieni Suresnes France DICLOFENAC CRISTERS 50 mg, comprimé gastrorésistant 50mg Gastro-resistant France EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex France DICLOFENAC EG 50 mg,comprimé gastro-résistant 50mg Gastro-resistant France MYLAN SAS 117, allée des Parcs Saint-Priest France DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant 25mg Gastro-resistant France MYLAN SAS 117, allée des Parcs Saint-Priest France DICLOFENAC MYLAN 50 mg, comprimé gastro-résistant 50mg Gastro-resistant France SANDOZ 49, avenue Georges Pompidou Levallois-Perret France DICLOFENAC SANDOZ 50 mg, comprimé enrobé gastro-résistant 50mg Gastro-resistant coated France TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex France DICLOFENAC TEVA 25 mg, comprimé enrobé gastrorésistant 25mg Gastro-resistant coated 51

52 France TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex France DICLOFENAC TEVA 50 mg, comprimé enrobé gastrorésistant 50mg Gastro-resistant coated France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE 100 mg, suppositoire 100mg Suppository Rectal use France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE 25 mg, comprimé gastrorésistant 25mg Gastro-resistant France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE 50 mg, comprimé enrobé gastro-résistant 50mg Gastro-resistant coated France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE 75 mg/3 ml, solution injectable 75mg/3ml Solution for Intramuscular use France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE ENFANT, suppositoire 25mg Suppository Rectal use 52

53 France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE LP 100 mg, comprimé enrobé à libération prolongée 100mg Prolonged-release coated France NOVARTIS PHARMA 2-4, rue Lionel Terray Rueil-Malmaison France VOLTARENE LP 75 mg, comprimé enrobé à libération prolongée 75mg Prolonged-release coated France Pfizer Holding France 23-25, avenue du Docteur Lannelongue Paris France Misoprostol ARTOTEC 50 mg/0,2 mg, comprimé gastro-résistant 50mg 0,2mg Gastro-resistant France Pfizer Holding France 23-25, avenue du Docteur Lannelongue Paris France Misoprostol ARTOTEC 75 mg/0,2 mg, comprimé gastro-résistant 75mg 0.2mg Gastro-resistant France TEVA GmbH Graf-Arco-Str Ulm Xelaran Brausete 25 mg 25mg Effervescent oral use 1 A Pharma Keltenring Oberhaching Diclo 100 retard - 1 A Pharma 100mg Prolonged-release 53

54 1 A Pharma Keltenring Oberhaching Diclo 25-1 A Pharma 25mg Gastro-resistant 1 A Pharma Keltenring Oberhaching Diclo 50-1 A Pharma 50mg Gastro-resistant 1 A Pharma Keltenring Oberhaching Diclo 75 SL - 1 A Pharma 75mg Prolonged-release 1 A Pharma Keltenring Oberhaching Diclofenac- 1 A Pharma 100 mg Zäpfchen 100mg Suppository Rectal use 1 A Pharma Keltenring Oberhaching Diclofenac- 1 A Pharma 50 mg Zäpfchen 50mg Suppository Rectal use AbZ-Pharma GmbH Graf-Arco-Strasse Ulm Diclofenac AbZ 25 mg Tabletten 25mg Gastro-resistant AbZ-Pharma GmbH Graf-Arco-Strasse Ulm Diclofenac AbZ 50 mg Tabletten 50mg Gastro-resistant 54

55 AbZ-Pharma GmbH Graf-Arco-Strasse Ulm Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee München Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee München Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee München Actavis Deutschland GmbH & Co. KG Willy-Brandt-Allee München Diclofenac AbZ 50 mg Trinkten 50mg Dispersible Diclo Divido 75mg Prolonged-release capsule, hard Diclo-Divido long 75mg Prolonged-release capsule, hard Diclofenac-Actavis 100mg Prolonged-release 100 mg capsule Diclofenac-Actavis 50mg Gastro-resistant 50 mg capsule 55

56 ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac kalium Diclo AL akut 12,5 mg 12,5mg Film-coated Diclofenac AL mg Suppository Rectal use Diclofenac AL 25 25mg Gastro-resistant Diclofenac AL 50 50mg Gastro-resistant Diclofenac AL 50 50mg Suppository Rectal use Supp. 56

57 ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen AWD.pharma GmbH & Co. KG Wasastr Radebeul AWD.pharma GmbH & Co. KG Wasastr Radebeul Diclofenac AL i.m. 75mg Solution for Intramuscular use Diclofenac AL retard 100mg Prolonged-release Diclofenac kalium Diclofenac-Kalium AL 25mg Film-coated 25 mg Filmten Rewodina 25mg 25mg Gastro-resistant Rewodina 50mg 50 mg Gastro-resistant 57

58 AWD.pharma GmbH & Co. KG Wasastr Radebeul AWD.pharma GmbH & Co. KG Wasastr Radebeul AWD.pharma GmbH & Co. KG Wasastr Radebeul Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Rewodina dual 75 Kaps 75mg Capsule Rewodina uno mg Capsule Xelaran 50mg Effervescent Brausete 50 mg Dicloberl 100 mg 100mg Suppository Rectal use Zäpfchen Dicloberl 50 mg 50mg Gastro-resistent Tabletten 58

59 Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin betapharm Arzneimittel GmbH Kobelweg Augsburg betapharm Arzneimittel GmbH Kobelweg Augsburg betapharm Arzneimittel GmbH Kobelweg Augsburg betapharm Arzneimittel GmbH Kobelweg Augsburg betapharm Arzneimittel GmbH Kobelweg Augsburg Dicloberl N 75 75mg Solution for Intramuscular use Diclo dispers 50mg Dispersible Diclofenbeta mg Suppository Rectal use Diclofenbeta mg Prolonged-release retard Diclofenbeta 25 25mg Gastro-resistant Diclofenbeta 50 50mg Gastro-resistant 59

60 Chephasaar Chemisch- Pharmazeutische Fabrik GmbH Muehlstr Sankt Ingbert Diclo-saar 100 mg Retardte 100mg Prolonged-release Chephasaar Chemisch- Pharmazeutische Fabrik GmbH Muehlstr Sankt Ingbert Diclo-saar 50 mg magensaftresistente Tabletten 50mg Gastro-resistant Chephasaar Chemisch- Pharmazeutische Fabrik GmbH Muehlstr Sankt Ingbert Diclo-saar 75mg SF Injektionslösung 75mg Solution for Intramuscular use CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 100 mg Supp. 100mg Suppository Rectal use CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 25 mg Tabletten 25mg Gastro-resistant CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 50 mg Trinkten 50mg Dispersible 60

61 CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 50mg Supp. 50mg Suppository Rectal use CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 50mg Tabletten 50mg Gastro-resistant CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclo-CT 75mg/2ml Ampullen 75mg Solution for Intramuscular use CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclofenac kalium Diclo-CT akut 12,5 mg Filmten 12,5mg Film-coated Denk Pharma GmbH & Co. KG Prinzregentenstr München Diclo-Denk 100 mg Zäpfchen 100mg Suppository Rectal use Denk Pharma GmbH & Co. KG Prinzregentenstr München DICLO-DENK 100mg RETARD 100mg Prolonged-release Dexcel Pharma GmbH Carl-Zeiss-Str Alzenau Diclofenac Atid 50mg 50mg Gastro-resistant 61

62 Dexcel Pharma GmbH Carl-Zeiss-Str Alzenau DOCPHARM Arzneimittelvertrieb GmbH & Co. Kommanditgesellschaft auf Aktien Greschbachstr Karlsruhe Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str Sankt Augustin Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str Sankt Augustin Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg Diclofenac Atid retard 100mg Prolonged-release Diclafenac PB retard 100mg Prolonged-release 100mg Dolgit-Diclo mg Prolonged-release Dolgit-Diclo 50 50mg Gastro-resistant Myogit mg Suppository Rectal use 62

63 Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Myogit 25 25mg Gastro-resistant Myogit 50 50mg Gastro-resistant Diclo KD mg Suppository Rectal use Diclo KD 50 50mg Suppository Rectal use Diclo KD 50 50mg Gastro-resistant 63

64 Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin Dr. Kade Pharmazeutische Fabrik GmbH Rigistr Berlin hameln pharma plus gmbh Langes Feld Hameln Hermes Arzneimittel GmbH Georg-Kalb-Str Großhesselohe Hermes Arzneimittel GmbH Georg-Kalb-Str Großhesselohe Heumann Pharma GmbH & Generica Co. KG Südwestpark Nürnberg Diclo KD 75 akut 75mg Modified-release capsule, hard Diclo KD retard 100mg Prolonged-release Diclo-Weimer 75mg Solution for Intramuscular use Diclofenac Natrium 25mg Effervescent HERMES 25 mg Brauseten Diclofenac Natrium 50mg Effervescent HERMES 50 mg Brauseten Diclofenac mg Suppository Rectal use Heumann Supp. 64

65 Heumann Pharma GmbH & Generica Co. KG Südwestpark Nürnberg Heumann Pharma GmbH & Generica Co. KG Südwestpark Nürnberg Heumann Pharma GmbH & Generica Co. KG Südwestpark Nürnberg Heumann Pharma GmbH & Generica Co. KG Südwestpark Nürnberg Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Diclofenac 100 retard Heumenn 100mg Prolonged-release Diclofenac 25 25mg Gastro-resistant Heumenn Diclofenac 50 50mg Gastro-resistant Heumann Diclofenac 50 50mg Suppository Rectal use Heumenn Supp. Diclac 75mg Solution for Intramuscular use Diclac 100mg 100mg Suppository Rectal use Zäpfchen 65

66 Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Diclac 150 mg ID 150mg Prolonged-release Diclac 25 25mg Gastro-resistant Diclac 50 50mg Gastro-resistant Diclac 50 mg 50mg Suppository Rectal use Zäpfchen Diclac 75 mg ID 75mg Prolonged-release Diclac Dispers 50mg dispersible Diclofenac potassium Diclac Dolo 12,5 mg 12,5mg Film-coated 66

67 Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen HIKMA Farmaceutica (Portugal(, S.A. Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca Terrugem SNT Portugal Juta Pharma GmbH Gutenbergstr Flensburg Kappler Pharma Consult GmbH Fonyoder Str Leipheim KSK-Pharma Vertriebs AG Finkenstr Pfinztal-Berghausen Diclofenac potassium Diclac Dolo 25 mg 25mg Coated Diclac retard 100mg Prolonged-release Diclofenac Hikma 75 75mg Solution for Intramuscular use mg Jutafenac 100 mg 100mg Prolonged-release Retardten Diclofenac potassium Diclofen Kalium KPC 25mg Film-coated 25 mg Filmten Diclo KSK 50 mg 50mg Gastro-resistant 67

68 MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg Diclofenac MEDA 25 mg Brauseten 25mg Effervescent MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg Diclofenac MEDA 50 mg Brauseten 50mg Effervescent Mylan dura GmbH Wittichstr Darmstadt Diclofenac dura 100 mg Retardten 100mg Prolonged-release Mylan dura GmbH Wittichstr Darmstadt Diclofenac dura 100 mg Zäpfchen 100mg Suppository Rectal use Mylan dura GmbH Wittichstr Darmstadt Diclofenac dura 25 mg 25mg Gastro-resistant Mylan dura GmbH Wittichstr Darmstadt Diclofenac dura 50 mg 50mg Gastro-resistant Mylan dura GmbH Wittichstr Darmstadt Diclofenac Mylan 100 mg Retardten 100mg Prolonged-release 68