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

69 Novartis Consumer Health GmbH Zielstattstrasse München Novartis Consumer Health GmbH Zielstattstrasse München Novartis Consumer Health GmbH Zielstattstrasse München Novartis Consumer Health GmbH Zielstattstrasse München Novartis Consumer Health GmbH Zielstattstrasse München Diclofenac potassium Diclofenac NCH 25 mg 25mg Coated Diclofenac potassium Optalidon 25mg Coated Zahnschmerz mit Diclofenac 25 mg Diclofenac potassium Voltaren Dolo 12,5 12,5mg Film-coated mg Diclofenac potassium Voltaren Dolo 25 mg 25mg Coated Diclofenac potassium Voltaren Dolo 25 mg 25mg Coated 69

70 Novartis Consumer Health GmbH Zielstattstrasse München Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Diclofenac potassium Voltaren Dolo Liquid 12,5 mg 12,5mg Capsule, soft Combaren 50 mg/50 50 mg Film-coated Codein phosphate mg Filmten 50 mg hemihydrate Voltaren 100 mg 100mg Prolonged-release retard Voltaren 100 mg 100mg Suppository Rectal use Zäpfchen Voltaren 25 mg 25mg Gastro-resistant Voltaren 25 mg 25mg Suppository Rectal use Zäpfchen 70

71 Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Novartis Pharma GmbH Roonstrasse Nuernberg Pharmacia GmbH Linkstrasse Berlin Voltaren 50 mg 50mg Gastro-resistant Voltaren 50 mg 50mg Suppository Rectal use Zäpfchen Voltaren Dispers 50mg Dispersible Diclofenac potassium Voltaren K Migräne 50mg Coated 50mg Voltaren Plus 50 mg Film-coated Codeine phosphate 50mg/50mg 50 mg hemihydrate Filmten Diclofenac colestyramin Voltaren Resinat 140mg Capsule, hard Arthotec 50mg Coated Misoprostol 0,2mg 71

72 Pharmacia GmbH Linkstrasse Berlin Misoprostol Arthotec forte 75mg 0.2mg Coated ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 100 mg Zäpfchen 100mg Suppository Rectal use ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 100 mg Retardkapseln 100mg Prolonged-release capsule ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 25 mg magensaftresistente Tabletten 25mg Gastro-resistant ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 50 mg Dispersten 50mg Dispersible ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 50 mg magensaftresistente Tabletten 50mg Gastro-resistant ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 50 mg Zäpfchen 50mg Suppository Rectal use 72

73 ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 75 mg SL Retardkapseln 75mg Prolonged-release capsule ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacratiopharm 75mg/2ml Injektionslösung 75mg/2ml Solution for Intramuscular use ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac potassium Diclofenacratiopharm Lösung bei Migräne 50mg/1ml Oral drops, solution ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac potassium Diclofenacratiopharm Schmerzten 12,5 mg 12,5mg Film-coated Rotexmedica GmbH Arzneimittelwerk Bunsenstr Trittau Diclofenac SF- Rotexmedica 75mg/3ml Solution for Intramuscular use Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz 100 mg Retardten 100mg Prolonged-release 73

74 Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz 100 mg Zäpfchen 100mg Suppository Rectal use Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz 25 mg magensaftresistente Tabletten 25mg Gastro-resistant Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz 50 mg magensaftresistente Tabletten 50mg Gastro-resistant Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz 50 mg Zäpfchen 50mg Suppository Rectal use Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz parenteral 75mg Injektionslösung 75mg Solution for Intramuscular use Sandoz Pharmaceuticals GmbH Raiffeisenstr Holzkirchen Diclofenac Sandoz Uno 150 mg Retardten 150mg Prolonged-release sigapharm GmbH Temmlerstr Marburg/Lahn Sigafenac 50 mg Zäpfchen 50mg Suppository Rectal use 74

75 Stadapharm GmbH Stadastr Bad Vilbel Diclofenac STADA 100 mg Retardten 100mg Prolonged-release Stadapharm GmbH Stadastr Bad Vilbel Diclofenac STADA 100 mg Zäpfchen 100mg Suppository Rectal use Stadapharm GmbH Stadastr Bad Vilbel Diclofenac STADA 25mg magensaftresistente Tabletten 25mg Gastro-resistant Stadapharm GmbH Stadastr Bad Vilbel Diclofenac STADA 50mg magensaftresistente Tabletten 50mg Gastro-resistant Stadapharm GmbH Stadastr Bad Vilbel Diclofenac Stada 50mg Zäpfchen 50mg Suppository Rectal use Stadapharm GmbH Stadastr Bad Vilbel Diclofenac STADA N 75 mg/3 ml Injektionslösung 75mg/3ml Solution for Intramuscular use Stadapharm GmbH Stadastr Bad Vilbel Diclofenac potassium Diclofenac-Kalium STADA 12,5 mg Filmten 12,5mg Film-coated 75

76 Stadapharm GmbH Stadastr Bad Vilbel T & D Pharma GmbH Kleine Knopheide Lemgo T & D Pharma GmbH Kleine Knopheide Lemgo TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven Diclofenac potassium Diclofenac-Kalium STADA 25 mg Filmten 25mg Film-coated Allvoran 100 mg 100mg Prolonged-release Retard Allvoran SF 75mg/3ml Solution for Intramuscular use Allvoran 25mg 25mg Gastro-resistant Allvoran 50 mg 50mg Gastro-resistant Allvoran S 100mg 100mg Suppository Rectal use Allvoran S 50 mg 50mg Suppository Rectal use 76

77 TAD Pharma GmbH Heinz-Lohmann-Str Cuxhaven Allvoran uno 100mg Prolonged-release Temmler Werke GmbH Weihenstephaner Str München Diclo-Klinge 75mg magensaftresistente Hartkapsel 75mg Prolonged-release capsule, hard Temmler Werke GmbH Weihenstephaner Str München Diclo-Klinge 75mg spezial 75mg Prolonged-release capsule, hard Temmler Werke GmbH Weihenstephaner Str München Diclofenac spezial 100mg Klinge 100mg Prolonged-release capsule, hard Temmler Werke GmbH Weihenstephaner Str München Diclofenac spezial 75mg Klinge 75mg Prolonged-release capsule, hard Temmler Werke GmbH Weihenstephaner Str München Diclofenac Temmler 25 mg Hartkapseln 25mg Gastro-resistant capsule, hard Temmler Werke GmbH Weihenstephaner Str München Diclofenac Temmler SL 100mg Retardkapseln 100mg Prolonged-release capsule 77

78 Temmler Werke GmbH Weihenstephaner Str München Diclofenac Temmler SL 75mg Retardkapseln 75mg Prolonged-release capsule TEOFARMA S.R.L. Via F.Iii Cervi 8 I VALLE SALIMBENE (PV) Effekton 100 mg Retardten 100mg Prolonged-release TEOFARMA S.R.L. Via F.Iii Cervi 8 I VALLE SALIMBENE (PV) Effekton 100mg Zäpfchen 100mg Suppository Rectal use TEOFARMA S.R.L. Via F.Iii Cervi 8 I VALLE SALIMBENE (PV) Effekton 25 mg magensaftresistente Tabletten 25mg Gastro-resistant TEOFARMA S.R.L. Via F.Iii Cervi 8 I VALLE SALIMBENE (PV) Effekton 50 mg magensaftresistente Tabletten 50mg Gastro-resistant 78

79 TEOFARMA S.R.L. Via F.Iii Cervi 8 I VALLE SALIMBENE (PV) TEVA GmbH Graf-Arco-Str Ulm Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Walter Ritter GmbH & Co. Spaldingstr. 110 B Hamburg Walter Ritter GmbH & Co. Spaldingstr. 110 B Hamburg Effekton 75mg/3ml Injektionslösung 75mg/3ml Solution for Intramuscular use Xelaran 25mg Effervescent Brausete 25 mg Diclofenac potassium Diclotin 25 mg 25mg Film-coated Filmten Diclofenac potassium Diclotin 50 mg 50mg Film-coated Filmten Diclowal 100mg 100mg Prolonged-release retard DICLOWAL 50 50mg Gastro-resistant 79

80 Walter Ritter GmbH & Co. Spaldingstr. 110 B Hamburg Walter Ritter GmbH & Co. Spaldingstr. 110 B Hamburg Winthrop Arzneimittel GmbH Urmitzer Str Mülheim-Kärlich Winthrop Arzneimittel GmbH Urmitzer Str Mülheim-Kärlich Winthrop Arzneimittel GmbH Urmitzer Str Mülheim-Kärlich Winthrop Arzneimittel GmbH Urmitzer Str Mülheim-Kärlich DICLOWAL 75 mg 75mg Solution for Intramuscular use DICLOWAL Supp. 100mg Suppository Rectal use Monoflam 100mg 100mg Suppository Rectal use Monoflam 50mg 50mg Gastro-resistant Monoflam 50mg 50mg Suppository Rectal use Monoflam retard N 100mg Prolonged-release capsule, hard 80

81 Wörwag Pharma GmbH & Co.KG Calwer Str Böblingen Dignofenac 100 mg 100mg Prolonged-release Wörwag Pharma GmbH & Co.KG Calwer Str Böblingen Dignofenac 25mg 25mg Gastro-resistant Wörwag Pharma GmbH & Co.KG Calwer Str Böblingen Dignofenac 50 mg 50mg Gastro-resistant Greece PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS Dilou 9, Peristeri Attikis, Greece BATAFIL 75mg/3ml Solution for Intramuscular use, Intravenous use Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 75mg/3ml Solution for Intramuscular use, Intravenous use 81

82 Greece PHARMATHEN International S.A.Greece Dervenakiwn 4, Pallini Attikis Greece DELIMON 75mg/3ml Solution for Intramuscular use, Intravenous use Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, Greece VURDON 75mg/3ml Solution for Intramuscular use, Intravenous use Greece BROS EPE Avgis & Gallinis 15 N. Kifissia, Greece EVINOPON 75mg/3ml Solution for Intramuscular use, Intravenous use Greece DEMO ABEE 21ST Km National Highway Athens-Lamia, Greece URIGON 75mg/3ml Solution for Intramuscular use, Intravenous use Greece RAFARM AEBE Korinthou 12 N. Psychiko, Greece RUVOMINOX 75mg/3ml Solution for Intramuscular use, Intravenous use Greece ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines Achaias & Trizinias Nea Kifissia Greece RHEUMAVEK 75mg/3ml Solution for Intramuscular use, Intravenous use 82

83 Greece MEDICUS S.A Valaoritou 10 Metamorfosi Greece DIFEND 75mg/3ml Solution for Intramuscular use, Intravenous use Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 25mg Enteric filmcoated Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 50mg (Enteric coated) gastroresistant Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 100mg Film-coated sustained release Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 75mg Film-coated sustained release Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 50mg Dispersible 83

84 Greece PHARMATHEN International S.A.Greece Dervenakiwn 4, Pallini Attikis Greece DELIMON 25mg (Enteric coated) gastroresistant Greece PHARMATHEN International S.A.Greece Dervenakiwn 4, Pallini Attikis Greece DELIMON 50mg (Enteric coated) gastroresistant Greece D.A.S.T. BIOTECH Pharmaceutical Ltd Larissis 10 Pallini Greece FLEFARMIN 50mg (Enteric coated) gastroresistant Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, Greece VURDON 25mg (Enteric coated) gastroresistant Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, Greece VURDON 100mg Film-coated sustained release 84

85 Greece Greece Greece Greece Greece Greece BROS EPE Avgis & Gallinis 15 N. Kifissia, Greece BROS EPE Avgis & Gallinis 15 N. Kifissia, Greece DEMO ABEE 21ST Km National Highway Athens-Lamia, Greece DEMO ABEE 21ST Km National Highway Athens-Lamia, Greece RAFARM AEBE Korinthou 12 N. Psychiko, Greece RAFARM AEBE Korinthou 12 N. Psychiko, Greece EVINOPON 25mg (Enteric coated) gastroresistant EVINOPON 50mg (Enteric coated) gastroresistant URIGON 25mg (Enteric coated) gastroresistant URIGON 50mg (Enteric coated) gastroresistant RUVOMINOX 50mg Coated RUVOMINOX 25mg Coated 85

86 Greece Greece Greece Greece Greece ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines Achaias & Trizinias Nea Kifissia Greece ANGELINI PHARMA HELLAS S.A. of Manufacturing and Commerce of Medicines Achaias & Trizinias Nea Kifissia Greece Pfizer Hellas A.E. Messoghion Ave. 243 Neo Psychiko Greece PHARMANEL COMMERCE PHARMACEUTICAL S.A. Marathonos Avenue 106, Gerakas Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece RHEUMAVEK 25mg (Enteric coated) gastroresistant RHEUMAVEK 50mg (Enteric coated) gastroresistant ARTHROTEC 50mg Controlled release Misoprostol 0,2mg FENOCLOF 75mg Controlled release capsule Diclofenac potassium VOLTAREN ACTI-GO 25mg Coated 86

87 Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece Diclofenac potassium VOLTAREN ACTI-GO 50mg Coated Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece Diclofenac potassium VOLTAREN ACTI-GO 12,5mg Coated Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece Diclofenac potassium VOLTAREN FAST 50mg Powder for oral solution Greece Greece Greece PHARMASWISS HELLAS A.E. Pentelis Avenue 53 Vrilissia Greece PHARMASWISS HELLAS A.E. Pentelis Avenue 53 Vrilissia Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece DICLO DUO 75mg Controlled release capsule COUNTERFLAME 75mg Gastro-resistant capsule VOLTAREN 50mg Suppository Rectal use 87

88 Greece NOVARTIS (HELLAS) A.E.B.E. 12th Km National Highway No 1, Metamorfosi Attikis Greece VOLTAREN 100mg Suppository Rectal use Greece Greece Greece Greece Hungary HELP ABEE Valaoritou 10 Metamorfosi Attikis, Greece HELP ABEE Valaoritou 10 Metamorfosi Attikis, Greece BROS EPE Avgis & Gallinis 15 N. Kifissia, Greece RAFARM AEBE Korinthou 12 N. Psychiko, Greece Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary VURDON 50mg Suppository Rectal use VURDON 100mg Suppository Rectal use EVINOPON 50mg Suppository Rectal use RUVOMINOX 50mg Suppository Rectal use Diclofenac CATAFLAM 15mg/ml Oral drops, belsőleges suspension szuszpenziós cseppek 88

89 Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Hungary Sandoz Hungária Kft.,., Bartók Béla út Budapest, 1114 Hungary Hungary Sandoz Hungária Kft.,., Bartók Béla út Budapest, 1114 Hungary Hungary ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Hungary ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac CATAFLAM 50 mg bevont ta Diclofenac CATAFLAM-V 50 mg ta Diclofenac DICLAC 75 mg retard ta Diclofenac DICLAC 150 mg retard ta Diclofenac DICLOFENAC AL 50 mg végbélkúp Diclofenac DICLOFENAC AL 50 mg gyomornedvellenálló filmta 50mg Coated 50mg Tablet 75mg Prolonged-release 150mg Prolonged-release 50mg Suppository Rectal use 50mg Gastro-resistant film-coated 89

90 Hungary ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac DICLOFENAC AL 100 mg végbélkúp 100mg Suppository Rectal use Hungary ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac DICLOFENAC AL 75 mg/3 ml oldatos injekció 75mg/3ml Solution for Parenteral use, Intramuscular use Hungary PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 - Holešovice Czech Republic Diclofenac DICLOFENAC DUO PHARMAVIT 75 mg kemény kapszula 75mg Capsule, hard Hungary STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel Diclofenac DICLOFENAC STADA 100 mg retard filmta 100mg Prolonged-release film-coated Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a Budapest, 1145 Hungary Diclofenac DICLOFENAC- RATIOPHARM 25 mg filmta 25mg Film-coated 90

91 Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a Budapest, 1145 Hungary Diclofenac DICLOFENAC- RATIOPHARM 100 mg retard kemény kapszula 100mg Prolonged-release capsule, hard Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a Budapest, 1145 Hungary Diclofenac DICLOFENAC- RATIOPHARM 50 mg filmta 50mg Film-coated Hungary ratiopharm Hungária Kereskedelmi Kft. Uzsoki u. 36/a Budapest, 1145 Hungary Diclofenac DICLOFENAC- RATIOPHARM retard ta 150mg Prolonged-release Hungary TEVA Gyógyszergyár zrt. Pallagi út 13 Debrecen 4042 Hungary Diclofenac DICLOFENAC-TEVA 100 mg végbélkúp 100mg Suppository Rectal use Hungary PANNONPHARMA Gyógyszergyártó Kft. PannonPharma út 1. Pécsvárad 7720 Hungary Diclofenac DICLOMEL SR 100 mg retard ta 100mg Prolonged-release Hungary Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Orphenadrine citrate NEODOLPASSE oldatos infúzió 75mg/250ml 30mg/250ml Solution for infusion Parenteral use, Intravenous use 91

92 Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 100 mg retard filmta 100mg Prolonged-release film-coated Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 25 mg gyomornedvellenálló filmta 25mg Gastro-resistant film-coated Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 50 mg gyomornedvellenálló filmta 50mg Gastro-resistant film-coated Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 50 mg végbélkúp 50mg Suppository Rectal use Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 75 mg retard filmta 75mg Prolonged-release film-coated 92

93 Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN 75 mg/3 ml oldatos injekció 75mg/3ml Solution for Parenteral use; Intramuscular or intravenous infusion. Not applicable for bolus intravenous Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN DOLO 12,5 mg filmta 12,5mg Film-coated Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN DOLO 12,5 mg lágy kapszula 12,5mg Capsule, soft Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac VOLTAREN DOLO 25 mg bevont ta 25mg Coated Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út Budapest, 1114 Hungary Diclofenac potassium VOLTAREN DOLO 25 mg lágy kapszula 25mg Capsule, soft 93

94 Hungary Hungary Iceland Iceland Iceland Iceland IBSA Pharma Információs és Szolgáltató Kft. Fodor u. 54/B. Budapest 1124, Hungary TEVA Gyógyszergyár zrt. Pallagi út 13 Debrecen 4042 Hungary Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark Pfizer ApS Lautrupvang 8 DK-2750 Ballerup Denmark ratiopharm GmbH Graf-Arco Strasse Ulm Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Diclofenac FLECTOR RAPID 50 mg granulátum 50mg Granules Diclofenac FORTEDOL 50 mg 50mg Film-coated filmta Diclofenacum natrium Arthrotec 50mg Tablet Misoprostolum 0,2mg Diclofenacum natrium Arthrotec Forte 75mg Tablet Misoprostolum 0.2mg Diclofenacum INN Diclomex 50 mg Gastro-resistant natríum Diclofenacum natrium Diklofenak Mylan 50mg Gastro-resistant 94

95 Iceland Iceland Iceland Iceland Iceland Iceland Iceland Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Diclofenacum natrium Klofen L 100mg Prolonged-release capsule, hard Diclofenacum natrium Modifenac 75mg Modified-release capsule, hard Diclofenacum natrium Voltaren 100mg Suppository Rectal use Diclofenacum natrium Voltaren 25mg Gastro-resistant Diclofenacum natrium Voltaren 25mg/ml Solution for Intramuscular use Diclofenacum natrium Voltaren 50mg Suppository Rectal use Diclofenacum natrium Voltaren 50mg Gastro-resistant 95

96 Iceland Iceland Iceland Iceland Iceland Iceland Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Novaris Healthcare A/S Lyngbyvej 172 DK-2100 Københawn Ø Denmark Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenacum kalium Voltaren Dolo 12,5mg Film-coated Diclofenacum kalium Voltaren Dolo 12,5mg Capsule, soft Diclofenacum kalium Voltaren Dolo 25mg Coated Diclofenacum kalium Voltaren Rapid 50mg Coated Diclofenacum kalium Vóstar-S 25mg Film-coated Diclofenacum kalium Vóstar-S 50mg Film-coated 96

97 Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol 25 mg Gastro-Resistant Tablets 25mg Gastro-resistant Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol 50 mg Gastro-Resistant Tablets 50mg Gastro-resistant Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol 12.5mg Suppositories 12,5mg Suppository Rectal use Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol 100mg Suppositories 100mg Suppository Rectal use 97

98 Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol Ampoules 75mg/3ml, solution for 75mg/3ml Solution for Intramuscular use Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol Retard 100 mg Film-coated Prolonged Release Tablets 100mg Film-coated prolonged release Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Voltarol Retard 75 mg Film-coated Prolonged-release Tablets 75mg Film-coated prolonged release Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Diclofenac potassium Cataflam 25mg Coated Tablets 25mg Coated 98

99 Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Diclofenac potassium Cataflam 50 mg Coated Tablets 50mg Coated Ireland Novarits Pharmacetucials UK Ltd Frimley Business Park Frimley Camberley, GU16 7SR Surrey Diclofenac potassium Voltfast Sachets 50 mg Powder for Oral Solution 50mg Powder for oral solution Ireland Novartis Consumer Health UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL Diclofenac potassium Diclofenac potassium NCH 12.5mg Filmcoated s 12,5mg Film-coated Ireland Novartis Consumer Health UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL Diclofenac potassium Otriflu 12.5mg Filmcoated Tablets 12,5mg Film-coated 99

100 Ireland Pinewood Laboratories Ltd (T/A Pinewood Heathcare) Ballymacarbry Clonmel, Co. Tipperary Ireland Diclo 75mg prolonged release s. 75mg Prolonged-release Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac 75 mg Prolonged -Release Tablets 75mg Prolonged-release Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac Retard 100 mg Prolongedrelease Tablets 100mg Prolonged-release Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac 25 mg Gastro-resistant Tablets 25mg Gastro-resistant Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac 50 mg Gastro-resistant Tablets 50mg Gastro-resistant Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac 100 mg Suppositories 100mg Suppository Rectal use Ireland Rowex Ltd Bantry, Co. Cork Ireland Diclac 25 mg/ml Solution for Injection 3 ml Ampoule 25mg Solution for Intramuscular use 100

101 Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Arthrotec 50 modified release s 50mg Modified-release Ireland Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland Arthrotec 75 modified-release s 75mg Modified-release Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene 25mg Capsules 25mg Capsule Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene 50mg Capsules 50mg Capsule 101

102 Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene 75 mg Dual Release Capsules 75mg Dual release capsule Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene 100 mg Dual Release Capsules 100mg Dual release capsule Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene ampoules 75 mg/3 ml Solution for Injection or Concentrate for Solution for Infusion 75mg/3ml Solution for or concentrate for solution for infusion Intramuscular use, Intravenous use Ireland Astellas Pharma Co. Ltd 5 Waterside Citywest Busniess Campus Naas Road Dublin 24 Ireland Difene 100mg Suppositories 100mg Suppository Rectal use Ireland Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenac potassium Kyflam 50mg Film Coated Tablet 50mg Film-coated 102

103 Ireland Ireland Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Diclofenac Sodium Misoprostol Diclofenac 50 mg/misoprostol 200 micrograms modified release s 50mg 0.2mg Modified Release Tablet Diclofenac Sodium Diclofenac 75 75mg Modified Release Misoprostol mg/misoprostol 0.2mg Tablet 200 micrograms modified release s Diclofenac VOLTAREN 50mg Soluble Diclofenac VOLTAREN 50mg Gastro-resistant Diclofenac VOLTAREN 75mg Prolonged-release Diclofenac VOLTAREN 100mg Prolonged-release 103

104 Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Farma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 Darvia Siena Bayer S.p.a. Viale Certosa, 130 Milano CostanzaFarma srl Via Taranto Milano CostanzaFarma srl Via Taranto Milano Diclofenac VOLTAREN 100mg Suppository Rectal use Diclofenac VOLTAREN 75mg/3ml Solution for Intramuscular use Diclofenac sodico ALGOSENAC 75mg/3ml Solution for Intramuscular use Diclofenac BAIFENAC 50mg Granules hydroxyethylpyrrolidine Diclofenac sodico DEALGIC 75mg Prolonged-release capsule, hard Diclofenac sodico DEALGIC 100mg Prolonged-release capsule, hard 104

105 DAICHI SANKYO Italia S.p.a. Via Paolo Di Dono , Rome DAICHI SANKYO Italia S.p.a. Via Paolo Di Dono , Rome DAICHI SANKYO Italia S.p.a. Via Paolo Di Dono , Rome Crinos S.p.a. Via Pavia, 6 Milano Crinos S.p.a. Via Pavia, 6 Milano Sandoz S.p.a. Largo Umberto Boccioni, 1 Origgio, Varese Sandoz S.p.a. Largo Umberto Boccioni, 1 Origgio, Varese Diclofenac sodico DEFLAMAT 25mg/ml Solution for Intramuscular use Diclofenac sodico DEFLAMAT 75mg Prolonged-release capsule, hard Diclofenac sodico DEFLAMAT 100mg Prolonged-release capsule, hard Diclofenac sodico DICLOFAN 100mg Prolonged-release Diclofenac sodico DICLOFAN 75mg/3ml Solution for Intramuscular use Diclofenac sodico DICLOFENAC 75mg/3ml Solution for Intramuscular use Diclofenac sodico DICLOFENAC 100mg Suppository Rectal use 105

106 Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 50mg Suppository Rectal use Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 100mg Suppository Rectal use Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 25mg Tablet Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 75mg/3ml Solution for Intramuscular use Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 50mg Tablet Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 100mg Prolonged-release Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Diclofenac sodico DICLOFENAC ALPHA BIOTECH 150mg Prolonged-release capsule 106

107 Alpha Biotech S.r.l. Via Ragazzi del 99 5, Bologna Almus S.r.l. Via Cesarea, 11/10 Genova Angenerico S.p.a. Via Nocera Umbra 75 Roma Angenerico S.p.a. Via Nocera Umbra 75 Roma Angenerico S.p.a. Via Nocera Umbra 75 Roma Angenerico S.p.a. Via Nocera Umbra 75 Roma Doc Generici S.r.l. Via Manuzio 7 Milano Diclofenac sodico DICLOFENAC ALPHA BIOTECH 25mg/ml Oral drops, solution Diclofenac sodico DICLOFENAC ALMUS 75mg/3ml Solution for Intramuscular use Diclofenac sodico DICLOFENAC 75mg/3ml Solution for Intramuscular use ANGENERICO Diclofenac sodico DICLOFENAC 100mg Suppository Rectal use ANGENERICO Diclofenac sodico DICLOFENAC 50mg Gastro-resistant ANGENERICO Diclofenac sodico DICLOFENAC 25mg Gastro-resistant ANGENERICO Diclofenac sodico DICLOFENAC DOC 75mg/3ml Solution for Intramuscular use 107

108 Doc Generici S.r.l. Via Manuzio 7 Milano Doc Generici S.r.l. Via Manuzio 7 Milano EG S.p.a Via Scarlatti, 31 Milano EG S.p.a Via Scarlatti, 31 Milano EG S.p.a Via Scarlatti, 31 Milano EG S.p.a Via Scarlatti, 31 Milano Germed Pharma S.p.a. Via Cantu, 11, Balsamo Milano, Diclofenac sodico DICLOFENAC DOC GENERICI 75mg Prolonged-release Diclofenac sodico DICLOFENAC DOC 100mg Prolonged-release GENERICI Diclofenac sodico DICLOFENAC EG 75mg/3ml Solution for Intramuscular use Diclofenac sodico DICLOFENAC EG 50mg Gastro-resistant Diclofenac sodico DICLOFENAC EG 100mg Prolonged-release Diclofenac sodico DICLOFENAC EG 100mg Suppository Rectal use Diclofenac sodico DICLOFENAC 75mg/3ml Solution for Intramuscular use GERMED 108

109 HEXAL S.p.a. Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 Brianza, Milano, HEXAL S.p.a. Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 Brianza, Milano, HEXAL S.p.a. Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 Brianza, Milano, HEXAL S.p.a. Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 Brianza, Milano, Mylan S.p.a. Via Vittor Pisani, 20 Milano Diclofenac sodico DICLOFENAC HEXAL 75mg/3ml Solution for Intramuscular use Diclofenac sodico DICLOFENAC HEXAL 100mg Suppository Rectal use Diclofenac sodico DICLOFENAC HEXAL 50mg Gastro-resistant Diclofenac sodico DICLOFENAC HEXAL 25mg Gastro-resistant Diclofenac sodico DICLOFENAC MYLAN 100mg Prolonged-release GENERICS 109

110 Mylan S.p.a. Via Vittor Pisani, 20 Milano Sandoz S.p.a. Largo Umberto Boccioni, 1 Origgio, Varese Biologici Italia Laboratories S.r.l. Via Serpero, 2 Masate, Milano 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) Diclofenac sodico DICLOFENAC MYLAN GENERICS 100mg Suppository rectal use Diclofenac sodico DICLOFENAC 100mg Prolonged-release SODICO Diclofenac sodico DICLOFENAC 75mg/3ml Solution for Intramuscular use SODICO BIL Diclofenac sodico DICLOREUM 50mg Suppository rectal use Diclofenac sodico DICLOREUM 100mg Suppository rectal use Diclofenac sodico DICLOREUM 75mg/3ml Solution for Intramuscular use 110

111 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) 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) Diclofenac sodico DICLOREUM 100mg Prolonged-release Diclofenac sodico DICLOREUM 150mg Prolonged-release capsule, hard Diclofenac sodico DICLOREUM 50mg Granules Diclofenac sodico DICLOREUM 50mg Gastro-resistant Diclofenac sodico DICLOREUM 25mg/ml Oral drops, solution Diclofenac sodico DICLOREUM 46,5mg/ml Oral drops, solution Diclofenac DIEP 25mg Gastro-resistant hydroxyethylpyrrolidine 111

112 Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenac hydroxyethylpyrrolidine DIEP 25mg Granules for oral suspension Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenac potassico EMINOCS 50mg Oral drops, solution Proge Farm S.r.l. Largo Donegani 4/a Novara Diclofenac sodico FENADOL 100mg Prolonged-release Wellington Street Development Pharma Limited 47 Oaklands Drive Rathgar Dublin 6 Ireland Diclofenac sodico FENDER 75mg/3ml Solution for Intramuscular use Wellington Street Development Pharma Limited 47 Oaklands Drive Rathgar Dublin 6 Ireland Diclofenac sodico FENDER 100mg Prolonged-release Bayer S.p.a. Viale Certosa, 130 Milano Diclofenac hydroxyethylpyrrolidine FLECTOR DOLORE 25mg Granules for oral solution 112

113 Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi 3, Firenze FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica 3/a, Abano Terme Padova FIDIA Farmaceutici S.p.a. Via Ponte della Fabbrica 3/a, Abano Terme Padova Scandinavian Regulatory Services, AB Svardvagen 3B Stockholm SE Sweden Scandinavian Regulatory Services, AB Svardvagen 3B Stockholm SE Sweden Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Diclofenac sodico FLOGOFENAC 100mg Prolonged-release capsule, hard Diclofenac potassico ITAMIFAST 25mg Film-coated Diclofenac potassico ITAMIFAST 50mg Film-coated Diclofenac potassico KAPPADI 25mg Film-coated Diclofenac potassico KAPPADI 50mg Film-coated Diclofenac sodico NOVAPIRINA 25mg Coated 113

114 O. P. PHARMA S.r.l. Via Torino 51 Milano O. P. PHARMA S.r.l. Via Torino 51 Milano Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Novartis Pharma S.p.A. Largo Umberto Boccioni, 1 Origgio Varese Diclofenac sodico TRAULEN 100mg Film-coated Diclofenac sodico TRAULEN 75mg/3ml Solution for Intramuscular use Diclofenac sodico VOLTADVANCE 25mg Powder for oral solution Diclofenac sodico VOLTADVANCE 25mg Film-coated Diclofenac potassico VOLTFAST 50mg Coated Diclofenac potassico VOLTFAST 25mg Coated Diclofenac potassico VOLTFAST 50mg Granules for oral solution 114

115 Altergon Italia S.r.l. Via Dell'Industria Pietradefusi Avellino Diclofenac INFORCE 75mg/ml Solution for Intramuscular use, Subcutaneous use Altergon Italia S.r.l. Via Dell'Industria Pietradefusi Avellino Diclofenac sodico INDICAM 75mg/ml Solution for Intramuscular use, Subcutaneous use Pfizer Italia S.r.l. Via Isonzo 71 Latina Diclofenac sodico Misoprostolo MISOFENAC 50mg 0,2mg Tablet Pfizer Italia S.r.l. Via Isonzo 71 Latina Diclofenac sodico Misoprostolo MISOFENAC 75mg 0.2mg Modified-release Pfizer Italia S.r.l. Via Isonzo 71 Latina Diclofenac sodico Misoprostolo ARTROTEC 50mg 0,2mg Tablet Pfizer Italia S.r.l. Via Isonzo 71 Latina Diclofenac sodico Misoprostolo ARTROTEC 75mg 0.2mg Modified-release HEXAL AG S.p.a. Industriestrasse, 25, D HOLZKIRCHEN Diclofenac sodico DICLOFENAC HEXAL AG 100mg Prolonged-release oral use 115

116 ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac sodico DICLOFENAC RATIOPHARM 50mg Gastro-resistant oral use ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac sodico DICLOFENAC RATIOPHARM 75mg/3ml solution for Intramuscular use Latvia Cipla (UK) Ltd The Old Post House Heath Road,Weybridge Surrey KT138TS Diclofenacum natricum Profenac 75 mg/3 ml solution for 75mg/3ml Solution for Intramuscular use Latvia Cipla (UK) Ltd The Old Post House Heath Road,Weybridge Surrey KT138TS Diclofenacum natricum Profenac SR 100 mg prolonged-release s 100mg Prolonged-release Latvia ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum natricum Diclofenacratiopharm 50 mg gastro-resistant s 50mg Gastro-resistant Latvia ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum natricum Diclofenacratiopharm 25 mg gastro-resistant s 25mg Gastro-resistant 116

117 Latvia ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum natricum Diclofenacratiopharm uno 150 mg prolongedrelease s 150mg Prolonged-release Latvia ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum natricum Diclofenacratiopharm 75 mg/2 ml solution for 75mg/2ml Solution for Intramuscular use Latvia Cipla (UK) Ltd The Old Post House Heath Road,Weybridge Surrey KT138TS Diclofenacum natricum Diclogen 50 mg suppositories 50mg Suppository Rectal use Latvia Cipla (UK) Ltd The Old Post House Heath Road,Weybridge Surrey KT138TS Diclofenacum natricum Diclogen 100 mg suppositories 100mg Suppository Rectal use Latvia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenacum natricum Diclac 75 mg/3 ml solution for /infusion 75mg/3ml Solution for and infusion Intramuscular use, Intravenous use Latvia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenacum natricum Diclac 100 mg modified release s 100mg Modified-release 117

118 Latvia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenacum natricum Diclac ID 75 mg modified release s 75mg Modified-release Latvia Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenacum natricum Diclac ID 150 mg modified release s 150mg Modified-release Latvia G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenacum natricum Diclomelan retard 100 mg sustainedrelease s 100mg Prolonged-release Latvia G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenacum natricum Diclomelan 50 mg gastro-resistant s 50mg Gastro-resistant Latvia G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenacum natricum Diclomelan 100 mg suppositories 100mg Suppository Rectal use 118

119 Latvia G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenacum natricum Thiamini hydrochloridum Diclovit hard capsules 50 mg 50 mg Capsule, hard Pyridoxini hydrochloridum 50 mg Cyanocobalaminum 0,25 mg Latvia SIA Briz Rasas iela 5 Riga, LV-1057 Latvia Diclofenacum natricum Feloran 75 mg/3 ml solution for 75mg/3ml Solution for Intramuscular use, Intravenous use Latvia Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Lidocainum hydrochloridum Olfen 75 mg/20 mg/2 ml solution for 75mg/2ml 20mg/2ml Solution for Intramuscular use Latvia Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Olfen Lactab 50 mg gastro-resistant s 50mg Gastro-resistant 119

120 Latvia Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Olfen Depocaps 100 mg prolongedrelease capsules, hard 100mg Prolonged-release capsule, hard Latvia Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Olfen Rectocaps 100 mg rectal capsules 100mg Rectal capsule Rectal use Latvia Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Olfen Depotabs 75 mg prolonged release s 75mg Prolonged-release Latvia Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac potassium Dicuno 25 mg filmcoated s 25mg Film-coated 120

121 Latvia Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac potassium Dicuno 50 mg filmcoated s 50mg Film-coated Latvia Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Diclofenacum natricum Dicloberl 75 mg/3 ml solution for 75mg/3ml Solution for Intramuscular use Latvia Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Diclofenacum natricum Dicloberl 100 mg suppositories 100mg Suppository rectal use Latvia Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Diclofenacum natricum Dicloberl 50 mg gastro-resistant s 50mg Gastro-resistant Latvia Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Diclofenacum natricum Dicloberl retard 100 mg prolonged release capsules 100mg Prolonged-release capsule 121

122 Latvia Pharmaceutical Works POLPHARMA SA ul. Pelplińska Starogard Gdański Poland Diclofenacum natricum Majamil retard 100 mg prolongedrelease s 100mg Prolonged-release Latvia A/S Olainfarm Rupnicu iela 5 Olaine, LV 2114 Latvia Diclofenac potassium Dikloferol 50 mg coated s 50mg Coated Latvia SIA PharmaSwiss Latvia Gertrudes iela 54 5 Riga, LV 1011 Latvia Diclofenacum natricum Diclorapid 75 mg gastro-resistant capsules, hard 75mg Gastro-resistant capsule, hard Latvia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren 75 mg/3 ml solution for 75mg/3ml Solution for Intramuscular use, Intravenous use Latvia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenac potassium Voltaren Akti 12,5 mg film-coated s 12,5mg Film-coated Latvia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenac potassium Voltaren Akti 25 mg soft capsules 25mg Capsule, soft 122

123 Latvia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenacum natricum Voltaren Retard 100 mg modified-release film-coated s 100mg Modified-release Latvia Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenac potassium Cataflam 50 mg film-coated s 50mg Film-coated Latvia GlaxoSmithKline Latvia SIA Duntes iela 11 Riga LV Latvia Diclofenacum natricum Diclofenac 50 mg suppositories 50mg Suppository Rectal use Latvia GlaxoSmithKline Latvia SIA Duntes iela 11 Riga LV Latvia Diclofenacum natricum Diclofenac 100 mg suppositories 100mg Suppository Rectal use Latvia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenacum natricum Naklofen SR 100 mg prolonged-release s 100mg Prolonged-release Latvia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenacum natricum Naklofen 75 mg/3 ml solution for 75mg/3ml Solution for Intramuscular use 123

124 Latvia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenacum natricum Naklofen 50 mg gastro-resistant s 50mg Gastro-resistant Latvia Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Diclofenacum natricum Almiral 25 mg/ml solution for and infusion 25mg/ml Solution for and infusion Intramuscular use, Intravenous use Latvia CT Arzneimittel GmbH Graf-Arco-Strasse Ulm Diclofenacum natricum Diclo CT 75 mg/2 ml solution for 75mg/2ml Solution for Intramuscular use Lithuania Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenac Diclac 75mg/3ml Solution for /infusion Intramuscular use, Intravenous use Lithuania Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenac Diclac 100mg Prolonged-release Lithuania Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia Diclofenac Diclac ID 75mg Modified-release 124

125 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Sandoz d.d. Verovskova 57 SI-1000 Ljubljana Slovenia UAB PharmaSwiss Šeimyniškių g. 21B LT-09200, Vilnius Lithuania Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin UAB BERLIN CHEMIE MENARINI BALTIC Jasinskio g. 16 a, Vilnius Lithuania Diclofenac Diclac ID 150mg Modified-release Diclofenac DicloRapid 75mg Gastro-resistant capsule, hard Diclofenac Dicloberl 75mg/3ml Solution for Intramuscular use Diclofenac Dicloberl 50mg Gastro-resistant Diclofenac Dicloberl 100mg Suppository Rectal use Diclofenac Dicloberl retard 100mg Prolonged-release capsule, hard 125

126 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac Diclofenacratiopharm 50mg Gastro-resistant Diclofenac Diclofenacratiopharm 100mg Suppository Rectal use Diclofenac Diclofenacratiopharm 50mg Suppository Rectal use Diclofenac Diclofenacratiopharm 75mg/2ml Solution for Intramuscular use Diclofenac Diclofenacratiopharm 100mg Prolonged-release capsule, hard Diclofenac Diclofenacratiopharm 150mg Modified-release uno Diclofenac Diclomelan 100mg Suppository Rectal use 126

127 Lithuania G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac Diclomelan 50mg Gastro-resistant Lithuania G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Diclofenac Diclomelan retard 100mg Prolonged-release Lithuania UAB Corpus Medica Sukilėlių pr. 61 LT Kaunas Lithuania Diclofenac FELORAN 75mg/3ml Solution for Intramuscular use Lithuania Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark Diclofenac Feloran 100mg Prolonged-release Lithuania Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen 75mg/3ml Solution for Intramuscular use Lithuania Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen 50mg Gastro-resistant 127

128 Lithuania Lithuania Lithuania Lithuania Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia 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 Diclofenac Naklofen 50mg Suppository Rectal use Diclofenac Naklofen SR 100mg Prolonged-release Diclofenac Olfen Depocaps 100mg Prolonged-release capsule, hard Diclofenac Olfen Depotabs 75mg Prolonged-release 128

129 Lithuania Lithuania Lithuania Lithuania Lithuania 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 Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Diclofenac Olfen Lactab 50mg Gastro-resistant coated Diclofenac Olfen Rectocaps 100mg Rectal capsule Rectal use Diclofenac Voltaren 75mg/3ml Solution for Intramuscular use, /infusion Intravenous use Diclofenac Voltaren 100mg Suppository Rectal use Diclofenac Voltaren Akti 25mg Coated 129

130 Lithuania Lithuania Lithuania Lithuania Lithuania Lithuania Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Novartis Finland OY Metsänneidonkuja 10 FIN Espoo Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac Voltaren Akti 12,5mg Film-coated Diclofenac Voltaren Retard 100mg Prolonged-release Diclofenac Voltaren Akti 25mg Capsule, soft Diclofenac Cataflam 50mg Coated Diclofenac Dicuno 25mg Film-coated Diclofenac Dicuno 50mg Film-coated 130

131 Lithuania Lithuania Luxembourg Luxembourg Luxembourg Luxembourg Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal G.L. Pharma GmbH Schlossplatz 1 A-8502 Lannach Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Diclofenac Lidocaine Olfen 75mg/2ml 20mg/2ml Solution for Intramuscular use Diclofenac Diclovit 50 mg Capsule, hard Thiamine 50 mg Pyridoxine 50 mg Cyanocobalamin 0,25 mg Diclofenac potassium Cataflam 50mg Coated Diclac retard mg Prolonged-release Diclac 75 mg/3 ml 75mg solution for Intramuscular use Injektionslösung Diclac-100 Zäpfchen 100mg suppository Rectal use 131

132 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen Hexal AG Industriestraße 25 D Holzkirchen N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclac-25 25mg Gastro-resistant coated Diclac-50 50mg Gastro-resistant coated Diclac-50 Zäpfchen 50mg suppository Rectal use Diclofenac EG-25 25mg Coated Diclofenac EG-50 50mg Coated Diclofenac EG retard 75mg Prolonged-release 75 Diclofenac EG retard 100mg Prolonged-release

133 Luxembourg N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac EG 75 mg/3 ml solution injectable 75mg solution for Intramuscular use, Intravenous use Luxembourg N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium Diclofenac EG 100 suppositoire 100mg suppository Rectal use Luxembourg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Diclofenac Mylan-75 Retard 75mg Prolonged-release Luxembourg Mylan bvba Rozendal Businesspark Terhulpsesteenweg 6A B-1560 Hoeilaart Belgium Diclofenac Mylan- 100 Retard 100mg Prolonged-release Luxembourg ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Ratiopharm-100 Zäpfchen 100mg suppository Rectal use Luxembourg ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Ratiopharm-25 25mg Gastro-resistant coated 133

134 Luxembourg ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Ratiopharm-50 50mg Gastro-resistant coated Luxembourg ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Ratiopharm 75 mg/2 ml Injektionslösung 75mg solution for Intramuscular use Luxembourg ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Retard Ratiopharm mg Prolonged-release capsule, hard Luxembourg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5 B-1348 Louvain-la-Neuve Belgium Motifene-75 75mg Modified- release capsule, hard Luxembourg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium Polyflam-50 50mg Gastro-resistant coated Luxembourg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium Polyflam-75 75mg Prolonged-release Luxembourg Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium Misoprostol Arthrotec-50 50mg 0,2mg Modified-release capsule, hard 134

135 Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Luxembourg Continental Pharma Rijksweg, 12 B-2870 Puurs Belgium 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 Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Misoprostol Arthrotec-75 75mg 0.2mg Modified-release capsule, hard Voltaren mg suppository Rectal use Zäpfchen Voltaren-25 25mg Gastro-resistant coated Voltaren-50 50mg Gastro-resistant coated Voltaren injekt 75mg solution for Intramuscular use Diclofenac Voltaren resinat 145,6mg Capsule, hard colestyramine Voltaren Retard mg Prolonged-release 135

136 Luxembourg Malta Malta Malta Malta Novartis Consumer Health S.A. Medialaan, 40 B-1800 Vilvoorde Belgium 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 Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Diclofenac potassium Voltatabs 12,5mg Coated Diclofenac potassium Cataflam 25mg Coated Diclofenac potassium Cataflam 50mg Coated Diclofenac potassium Catafast 50mg Powder for oral solution Voltaren 12,5mg Suppository Rectal use 136

137 Malta Malta Malta Malta Malta 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 Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltaren 50mg Suppository Rectal use Voltaren 100mg Suppository Rectal use Voltaren 25mg Gastro-resistant Voltaren 50mg Gastro-resistant Voltaren 75mg/3ml Solution for Intramuscular use, intravenous use 137

138 Malta Malta Malta Malta Malta Malta 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 Proge Farm S.r.l. Largo Donegani 4/a Novara Proge Farm S.r.l. Largo Donegani 4/a Novara Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Voltaren 50mg Dispersible Voltaren 75mg Modified-release Voltaren 100mg Modified-release Fenadol 100mg Suppository Rectal use Fenadol 100mg Modified-release Diclofenac potassium Areston 50mg Film-coated 138

139 Malta Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Almiral 25mg s 25mg Gastro-resistant Malta Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Almiral 50mg s 50mg Gastro-resistant Malta Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Almiral 75mg/3ml Solution for Injection or Infusion Intramuscular use, intravenous use Malta Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Olfen-75 Ampoules 75mg/2ml Solution for Intramuscular use 139

140 Malta Malta Malta Malta 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 Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Olfen-25 Lactab 25mg Film-coated, gastro-resistant Olfen-50 Lactab 50mg Film-coated, gastro-resistant Olfen-100 Rectocaps 100mg Suppository Rectal use Olfen-75 SR 75mg Modified-release Depotabs 140

141 Malta Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Olfen-100 SR Depocaps 100mg Modified-release capsule Malta Remedica Ltd Limassol Industrial Estate Aharnon Street PO Box CY-3508 Limassol Cyprus Remethan 25mg Tablets 25mg Gastro-resistant Malta DEMO SA Pharmaceutical Industry 21st km National Road Athens-Lamia Athens Greece Urigon 75mg/3ml solution for 75mg/3ml Solution for Intramuscular use Norway Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac potassium Diclofenackalium Orifarm 25mg Film-coated Norway Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac potassium Diclofenackalium Orifarm 50mg Film-coated 141

142 Norway Norway Norway Norway Norway Norway Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Diclofenac potassium Voltarol 12,5mg Capsule, soft Diclofenac potassium Voltarol 25mg Capsule, soft Diclofenac potassium Voltarol 12,5mg Film-coated Diclofenac potassium Voltarol 25mg Coated Diclofenac potassium Cataflam 12,5mg Coated Diclofenac potassium Cataflam 50mg Coated Diclofenac potassium Cataflam 50mg Powder for oral solution 142

143 Norway Norway Norway Norway Norway Norway Norway Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac potassium Dicuno 25mg Film-coated Diclofenac potassium Dicuno 50mg Film-coated Diclofenac potassium Difenassium 25mg Film-coated Diclofenac potassium Difenassium 50mg Film-coated Diclofenac potassium Diclofenac Actavis 12,5mg Film-coated Modifenac 75mg Modified- release capsule, hard Diclofenac potassium DiclofenacKalium 50mg Film-coated ratiopharm 143

144 Norway Pfizer AS Lilleakerveien 2B 1324 Lysaker Norway Misoprostol Arthrotec 50mg 0,2mg Modified-release Norway ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac ratiopharm 25mg Gastro-resistant Norway ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac ratiopharm 50mg Gastro-resistant Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Voltaren 25mg Gastro-resistant Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Voltaren 50mg Gastro-resistant Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Voltaren 25mg/ml Solution for infusion /Concentrate for solution for infusion Parenteral use 144

145 Norway Norway Norway Norway Norway Poland Poland BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden BMM Pharma AB Blasieholmsgatan 2 SE Stockholm Sweden Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Novartis Norge AS Nydalen Alle 37 A 0484 Oslo Norway Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenac BMM Pharma 25mg Gastro-resistant Diclofenac BMM 50mg Gastro-resistant Pharma Voltaren 25mg Suppository Rectal use Voltaren 50mg Suppository Rectal use Voltaren 100mg Suppository Rectal use Diclofenac potassium Vostar 12,5mg Film-coated Diclofenacum natricum Dicloreum 50mg Gastro-resistant film-coated 145

146 Poland Poland Poland Poland Poland Poland Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin Berlin-Chemie AG (Menarini Group) Glienicker Weg Berlin GlaxoSmithKline Pharmaceuticals S.A. Grunwaldzka 189 Poznań Poland GlaxoSmithKline Pharmaceuticals S.A. Grunwaldzka 189 Poznań Poland Diclofenacum natricum Dicloreum 25mg/ml Solution for Intramuscular use Diclofenacum natricum Dicloreum retard 100mg Prolonged-release capsule Diclofenacum natricum Dicloberl retard 100mg Prolonged-release capsule Diclofenacum natricum Dicloberl 50 50mg Suppository Rectal use Diclofenacum natricum Diclofenac GSK 50mg Suppository Rectal use Diclofenacum natricum Diclofenac GSK 100mg Suppository Rectal use 146

147 Poland Poland Poland Poland Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia 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 Diclofenacum natricum Naklofen 25mg/ml Solution for Intramuscular use Diclofenacum natricum Naklofen Duo 75mg Prolonged-release capsule Diclofenacum natricum Olfen mg Rectal capsule Rectal use Diclofenacum natricum Olfen 50 50mg Rectal capsule Rectal use 147

148 Poland Poland Poland Poland 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 Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Diclofenacum natricum Lidocaini hydrochloridum Olfen 75 37,5mg/ml 10 mg/ml Solution for Intramuscular use Diclofenacum natricum Olfen 100 SR 100mg Prolonged-release capsule Diclofenacum natricum Olfen 25 25mg Film-coated Diclofenacum natricum Olfen 50 50mg Film-coated 148

149 Poland Poland Poland Poland Poland Poland Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Diclofenac potassium Voltaren Acti 12,5mg Film-coated Diclofenac potassium Voltaren Express 12,5mg Capsule, soft Diclofenac potassium Voltaren Acti Forte 25mg Film-coated Diclofenac potassium Voltaren Express 25mg Capsule, soft Forte Diclofenac potassium Cataflam 50 50mg Film-coated Diclofenacum natricum Voltaren 25mg/ml Solution for Intramuscular use, Intravenous use 149

150 Poland Poland Poland Poland Poland Poland Poland 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 Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9NJ Diclofenacum natricum Voltaren 50mg Gastro-resistant Diclofenacum natricum Voltaren SR mg Prolonged-release Diclofenacum natricum Voltaren SR 75 75mg Prolonged-release Diclofenacum natricum Voltaren 50mg Suppository Rectal use Diclofenacum natricum Voltaren 25mg Suppository Rectal use Diclofenacum natricum Voltaren 100mg Suppository Rectal use Diclofenacum Arthrotec Forte 75mg Tablet Misoprostolum 0.2mg 150

151 Poland Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9NJ Diclofenacum natricum Misoprostolum Arthrotec 50mg 0,2mg Tablet Poland PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 - Holešovice Czech Republic Diclofenacum natricum DicloDuo 75mg Modified-release capsule Poland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum Dicloratio Retard mg Prolonged-release capsule Poland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum Dicloratio 25 25mg Gastro-resistant Poland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum Lidocainum Dicloratio 75mg/2ml 20mg/2ml Solution for Intramuscular use Poland ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenacum Dicloratio 50 50mg Gastro-resistant 151

152 Poland Poland Poland Poland Poland Poland Poland 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 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 Diclofenacum Olfen UNO 150mg Prolonged-release capsule Diclofenacum Dicloratio mg Suppository Rectal use Diclofenacum Dicloratio 50 50mg Suppository Rectal use Diclofenacum natricum Diclac 75mg/3ml Solution for Intramuscular use Diclofenacum natricum Diclac 75 Duo 75mg Modified-release Diclofenacum natricum Diclac 150 Duo 150mg Modified-release Diclofenacum natricum Diclac mg Suppository Rectal use 152

153 Poland Poland Poland Poland Poland Poland Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul. Karolkowa 22/24 Warszawa Poland Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 Starogard Gdański Poland Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 Starogard Gdański Poland Diclofenacum natricum Diclac 50 50mg Suppository Rectal use Diclofenac potassium Dicuno 25mg Film-coated Diclofenac potassium Dicuno 50mg Film-coated Diclofenacum natricum Difadol 25mg/ml Solution for Intramuscular use, Intravenous use Diclofenacum natricum Majamil prolongatum 100mg Prolonged-release capsule Diclofenacum natricum Majamil PPH 25mg Gastro-resistant 153

154 Poland Portugal Portugal Portugal Portugal Portugal Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 Starogard Gdański Poland Laboratórios Pfizer, Lda. Lagoas Park, Edifício Porto Salvo Portugal Laboratórios Pfizer, Lda. Lagoas Park, Edifício Porto Salvo Portugal Alter, S.A. Estrada Marco do Grilo - Zemouto 2830 Coina Portugal Generis Farmacêutica, S.A. Rua João de Deus, Amadora Portugal Labesfal - Laboratórios Almiro S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Diclofenacum natricum Majamil PPH 50mg Gastro-resistant Diclofenac Arthrotec 50mg Tablet Misoprostol 0,2mg Diclofenac Arthrotec 75 75mg Modified-release Misoprostol 0.2mg Diclofenac Diclofenac Alter 50 50mg Coated mg Comprimidos Diclofenac Diclofenac Generis 50mg Coated 50 mg Comprimidos Revestidos Diclofenac Diclofenac Labesfal 100mg Suppository Rectal use 154

155 Portugal Labesfal - Laboratórios Almiro S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Diclofenac Diclofenac Labesfal 100mg Prolonged-release capsule, hard Portugal Labesfal - Laboratórios Almiro S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Diclofenac Diclofenac Labesfal 50mg Gastro-resistant Portugal Labesfal - Laboratórios Almiro, S.A. Campo de Besteiros Santiago de Besteiros Portugal Diclofenac Diclofenac Labesfal 75 mg/3ml Solução injectável 75mg/3ml Solution for Intramuscular use, Intravenous use Portugal Mylan, Lda. Rua Doutor António Loureiro Borges Edíficio Arquiparque 1 R/C Esqº Algés Portugal Diclofenac Diclofenac Mylan 100mg Prolonged-release capsule, hard 155

156 Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Rua Quinta do Pinheiro Edifício Tejo - 6º Piso Carnaxide Portugal Diclofenac Diclofenac Ratiopharm 50mg Gastro-resistant Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Rua Quinta do Pinheiro Edifício Tejo - 6º Piso Carnaxide Portugal Diclofenac Diclofenac Ratiopharm 100 mg Supositórios 100mg Suppository Rectal use Portugal Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda Rua Quinta do Pinheiro Edifício Tejo - 6º Piso Carnaxide Portugal Diclofenac Diclofenac Retard Ratiopharm 100mg Prolonged-release capsule, hard Portugal Sandoz Farmacêutica, Lda. Alameda da Beloura Edifício 1, 2º - Escritório Sintra Portugal Diclofenac Diclofenac Sandoz 50 mg Comprimidos revestidos 50mg Coated 156

157 Portugal Portugal Portugal Portugal Portugal Labesfal - Laboratórios Almiro S.A. Zona Industrial do Lagedo Santiago de Besteiros Portugal Laboratório B. A. Farma, Lda. Rua Prof. Sousa da Câmara, Lisboa Portugal Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova Amadora Portugal Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova Amadora Portugal Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova Amadora Portugal Diclofenac Dolacen 75mg/2ml Solution for Intramuscular use Diclofenac Dorcalor 50mg Gastro-resistant Diclofenac Fenil-V 75mg/2ml Solution for Intramuscular use Diclofenac Fenil-V 100mg Suppository Rectal use Diclofenac Fenil-V 50mg Gastro-resistant 157

158 Portugal Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova Amadora Portugal Diclofenac Fenil-V Retard 100mg Prolonged-release capsule, hard Portugal Laboratório Normal - Produtos Farmacêuticos, Lda. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Diclofenac Flameril 75mg/3ml Solution for Intramuscular use, Intravenous use Portugal Laboratório Normal - Produtos Farmacêuticos, Lda. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Diclofenac Flameril 100mg Suppository Rectal use Portugal Laboratório Normal - Produtos Farmacêuticos, Lda. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Diclofenac Flameril 50mg Gastro-resistant 158

159 Portugal Laboratório Normal - Produtos Farmacêuticos, Lda. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Diclofenac Flameril Retard 100mg Prolonged-release Portugal Portugal Portugal Portugal Mepha Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park Edificio 5-A, Piso Porto Salvo Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B Lisboa Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B Lisboa Portugal Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B Lisboa Portugal Diclofenac Olfen 50mg Gastro-resistant Diclofenac Painex 25 25mg Coated Diclofenac Painex 50 50mg Coated Diclofenac Painex R 100mg Prolonged-release capsule, hard 159

160 Portugal Portugal Portugal Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Diclofenac Voltaren 100mg Suppository Rectal use Diclofenac Voltaren 75mg/3ml Solution for Intramuscular use, Intravenous use Diclofenac Voltaren 50mg Gastro-resistant Diclofenac Voltaren 75 75mg Prolonged-release 160

161 Portugal Portugal Portugal Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Laboratório Normal - Produtos Farmacêuticos, Lda. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Novartis Consumer Health Produtos Farmacêuticos e Nutrição, Lda. Rua do Centro Empresarial, Edf 8, Quinta da Beloura Sintra Portugal Novartis Consumer Health Produtos Farmacêuticos e Nutrição, Lda. Rua do Centro Empresarial, Edf 8, Quinta da Beloura Sintra Portugal Diclofenac Voltaren Retard 100mg Prolonged-release Diclofenac Cataflam 50mg Coated Diclofenac Otriflu 12,5mg Coated Diclofenac Voltaren 12,5 12,5mg Film-coated 161

162 Portugal Portugal Portugal Portugal Novartis Consumer Health Produtos Farmacêuticos e Nutrição, Lda. Rua do Centro Empresarial, Edf 8, Quinta da Beloura Sintra Portugal Novartis Consumer Health Produtos Farmacêuticos e Nutrição, Lda. Rua do Centro Empresarial, Edf 8, Quinta da Beloura Sintra Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial Edifício 8, Quinta da Beloura Sintra Portugal Laboratórios Vitória, S.A. Rua Elias Garcia, 28 - Venda Nova Amadora Portugal Diclofenac Voltaren 12,5 12,5mg Capsule, soft Diclofenac Voltaren 25 25mg Capsule, soft Diclofenac Voltaren Rapid 50mg Coated Diclofenac Fenil-V Dispersivel 46,5mg Dispersible 162

163 Romania PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c Praha 7 - Holešovice Czech Republic Diclofenacum DICLOFENAC DUO PHARMASWISS 75 mg 75mg Prolonged-release capsule, hard Romania Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenacum DICLOREUM 150 mg 150mg Prolonged-release capsule, hard Romania Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Diclofenacum TRATUL 50 mg 50mg Gastro-resistant capsule, soft Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj-Napoca România Diclofenacum DICLOTARD 100 mg 100mg Prolonged-release Romania Hexal AG Industriestraße 25 D Holzkirchen Diclofenacum DICLAC 75 ID 75mg Modified-release Romania Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Diclofenacum VOLTAREN RETARD 100mg Prolonged-release 163

164 Romania STADA HEMOFARM S.R.L. Str. Zugrav Nedelcu nr.3, Timişoara Judeţul Timiş România Diclofenacum REFEN RETARD 100mg Prolonged-release Romania S.C. AC HELCOR PHARMA SRL Str. Victor Babeş nr. 50 Baia-Mare Jud. Maramureş România Diclofenacum DICLOFENAC 50 mg 50mg Gastro-resistant Romania SC ANTIBIOTICE SA Str. Valea Lupului nr Iaşi România Diclofenacum CLAFEN 50 mg 50mg Gastro-resistant Romania FARAN LABORATORIES S.A. 17 km Athens-Lamia Achaias şi Trizinas Nea Kifisia Greece Diclofenacum RHEUMAVEK 25mg Gastro-resistant Romania Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Diclofenacum VOLTAREN 50 50mg Gastro-resistant Romania Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Diclofenacum VOLTAREN 25 25mg Gastro-resistant 164

165 Romania Romania Romania Romania Romania Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj-Napoca România Novartis Pharma GmbH Roonstrasse 25 Nuernberg D S.C. ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2; Bucuresti România S.C. ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2; Bucuresti România S.C. MEDUMAN S.A. Str. Aleea Eroilor nr. 28 Vişeu de Sus Judeţul Maramureş România Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Diclofenacum DICLOFENAC 50 mg 50mg Gastro-resistant Diclofenacum VOLTAREN RAPID 50mg Coated Diclofenacum DICLOFENAC ARENA 25mg Coated 50 mg Diclofenacum DICLOFENAC ARENA 50mg Coated 50 mg Diclofenacum N - DICLOFENAC 50mg Coated Diclofenacum VOLTAREN 25mg/ml Solution for Intramuscular use, Intravenous use 165

166 Romania ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenacum DICLOFENAC AL I.M. 75mg/3ml Solution for Intramuscular use Romania Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Diclofenacum TRATUL 30mg/ml Solution for Intramuscular use Romania Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Diclofenacum ALMIRAL 75mg/3ml Solution for Intramuscular use, Intravenous use Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj-Napoca România Diclofenacum DICLOFENAC 75 mg 75mg/3ml Solution for Intramuscular use Romania STADA HEMOFARM S.R.L. Str. Zugrav Nedelcu nr.3, Timişoara Judeţul Timiş România Diclofenacum REFEN 75 mg 25mg/ml Solution for Intramuscular use, Intravenous use Romania FARAN LABORATORIES S.A. 17 km Athens-Lamia Achaias şi Trizinas Nea Kifisia Greece Diclofenacum RHEUMAVEK 25mg/ml Solution for Intramuscular use 166

167 Romania Romania Romania Romania Romania Romania Romania Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Vienna SC ANTIBIOTICE SA Str. Valea Lupului nr Iaşi România Novartis Pharma GmbH Roonstrasse 25 Nuernberg D Novartis Pharma GmbH Roonstrasse 25 Nuernberg D S.C. MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr. 82A Constanţa România S.C. MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr. 82A Constanţa România Diclofenacum TRATUL 120 mg 120mg Suppository Rectal use Diclofenacum TRATUL 60 mg 60mg Suppository Rectal use Diclofenacum CLAFEN 100 mg 100mg Suppository Rectal use Diclofenacum VOLTAREN 100mg Suppository Rectal use Diclofenacum VOLTAREN 50mg Suppository Rectal use Diclofenacum DICLOFENAC SODIC 100mg Suppository Rectal use 100 mg Diclofenacum DICLOFENAC mg Suppository Rectal use mg 167

168 Romania Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Orphenadrine citrate Neodolpasse 75mg/250ml 30mg/250ml Solution for infusion Intravenous use Romania PFIZER EUROPE MA EEIG Ramsgate Road Sandwich Kent CT13 9NJ Diclofenacu Misoprostolum ARTHROTEC 75 75mg 0.2mg Gastro resistant Romania Lannacher Heilmittel Ges.m.b.H Schlossplatz Lannach Thiamine hydrochloride Pyridoxine hydrochloride TRATUL PLUS 50mg 50mg 50mg Gastro resistant Cyanocobalamin 0,25mg Slovak Republic MEDOPHARM s.r.o., Lehárova 1808/ , Praha 4 Czech Republic Diclofenac ALMIRAL 75mg/3ml Solution for Intramuscular use, Intravenous use Slovak Republic Medochemie Ltd 1-10 Constantinoupoleos str P.O. Box Limassol 3505 Cyprus Diclofenac ALMIRAL 50 mg 50mg Gastro-resistant 168

169 Slovak Republic Hexal AG Industriestraße 25 D Holzkirchen Diclofenac Diclac retard 100mg Prolonged-release Slovak Republic ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Diclobene 150 mg retard 150mg Prolonged-release Slovak Republic ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Diclobene 25 mg 25mg Gastro-resistant Slovak Republic ratiopharm GmbH Graf Arco Strasse 3 D Ulm Diclofenac Diclobene 50 mg 50mg Gastro-resistant Slovak Republic ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac Diclofenac AL 25 25mg Gastro-resistant Slovak Republic ALIUD PHARMA GmbH & Co. KG Gottlieb Daimler Strasse 19 D Laichingen Diclofenac Diclofenac AL 50 50mg Gastro-resistant 169

170 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak 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) diclofenac Diclofenac AL retard 100mg Prolonged-release Diclofenac Diclofenac Duo 75mg Modified-release PharmaSwiss 75 mg capsule Diclofenac DICLOREUM 25 mg 25mg Gastro-resistant Diclofenac DICLOREUM 50 mg 50mg Gastro-resistant Diclofenac DICLOREUM 50 mg 50mg Suppository Rectal use Diclofenac DICLOREUM 100 mg 100mg Suppository Rectal use 170

171 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) 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 diclofenac DICLOREUM 75 mg 75mg/3ml Solution for Intramuscular use Diclofenac DICLOREUM retard 100mg Prolonged-release Diclofenac Dicuno 25 mg 25mg Film-coated filmom obalené y Diclofenac Dicuno 50 mg 50mg Film-coated filmom obalené y Diclofenac Dolmina 50 50mg Film-coated Diclofenac DOLMINA INJ 75mg/3ml Solution for Intramuscular use 171

172 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic IBSA Slovakia s.r.o. Mytna Bratislava Slovak Republic Dr. R. Pfleger Chemische Fabrik GmbH Dr.Robert Pfleger Strasse 12 D Bamberg 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 Diclofenac Flector EP Rapid 50 mg 50mg Granules Diclofenac Myogit 50 50mg Gastro-resistant Diclofenac VERAL 100 mg 100mg Suppository Rectal use Diclofenac VERAL 100 retard 100mg Prolonged-release Diclofenac VERAL 25 mg 25mg Gastro-resistant Diclofenac VERAL 50 mg 50mg Gastro-resistant 172

173 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Herbacos Recordati s.r.o. Štrossova Pardubice Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Diclofenac VERAL 75 75mg/3ml Solution for Intramuscular use Diclofenac VERAL 75 retard 75mg Prolonged-release Diclofenac Voltaren mg Suppository Rectal use Diclofenac Voltaren 50 50mg Gastro-resistant Diclofenac Voltaren 75 mg/3 ml 75mg/3ml Solution for Intramuscular use Diclofenac Voltaren Actigo Extra 25 mg 25mg Coated Diclofenac Voltaren Rapid 12,5 12,5mg Capsule, soft mg 173

174 Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Slovak Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Novartis s.r.o. Na Pankraci 1724/ Praha 4 Czech Republic Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9NJ Fresenius Kabi GmbH Hafnerstrasse 36 Graz A-8055 Diclofenac Voltaren Rapid 25 mg 25mg Capsule, soft Diclofenac Voltaren Rapid 50 50mg Coated mg Diclofenac Voltaren Rapid 50mg Powder for oral Sachets solution Diclofenac Voltaren Retard mg Prolonged-release Diclofenac Voltaren SR 75 75mg Prolonged-release Diclofenac ARTHROTEC FORTE 75mg Film-coated Misoprostol 0.2mg Diclofenac Neodolpasse 75mg/250ml Solution for Intravenous use Orphenadrine 30mg/250ml infusion 174

175 Slovenia PharmaSwiss d.o.o. Wolfova Ljubljana Slovenia Diclofenac Diclo Duo 75 mg trde gastrorezistentne kapsule 75mg Gastro-resistant capsule, hard Slovenia PharmaSwiss d.o.o. Wolfova Ljubljana Slovenia Diclofenac DicloJet 75 mg trde gastrorezistentne kapsule 75mg Gastro-resistant capsule, hard Slovenia Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac Dicuno 25 mg filmsko obložene e 25mg Film-coated Slovenia Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Diclofenac Dicuno 50 mg filmsko obložene e 50mg Film-coated Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen 25 mg/ml raztopina za injiciranje 25mg/ml Solution for Intramuscular use Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia diclofenac Naklofen 50 mg gastrorezistentne e 50mg Gastro-resistant 175

176 Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen 50 mg svečke 50mg Suppository Rectal use Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen duo 75 mg trde kapsule 75mg Capsule, hard Slovenia Krka, d.d. Novo mesto Šmarješka cesta Novo mesto Slovenia Diclofenac Naklofen SR 100 mg e s podaljšanim sproščanjem 100mg Prolonged-release Slovenia Medias International d.o.o. Leskoškova cesta 9D 1000 Ljubljana Slovenia Diclofenac Neodolpasse 75 mg/30 mg raztopina za infundiranje 2,5mg/ml Solution for infusion Intravenous use Slovenia Pliva Ljubljana d.o.o. pot k sejmišču Ljubljana Črnuče Slovenia Diclofenac Olfen 100 mg trde kapsule s podaljšanim sproščanjem 100mg Prolonged-release capsule, hard Slovenia Pliva Ljubljana d.o.o. pot k sejmišču Ljubljana Črnuče Slovenia Diclofenac Voltaren 12,5 mg svečke 12,5mg Suppository Rectal use 176

177 Slovenia Pliva Ljubljana d.o.o. pot k sejmišču Ljubljana Črnuče Slovenia Diclofenac Voltaren 25 mg svečke 25mg Suppository Rectal use Slovenia Novartis Consumer Health GmbH Zielstattstrasse 40 Munchen Diclofenac Voltaren Dolo 12,5 mg filmsko obložene e 12,5mg Film-coated Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain VOLTAREN 100 mg supositorios 100mg Suppository Rectal use Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain VOLTAREN 50 mg comprimidos gastrorresistentes 50mg Gastro-resistant Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain DOLO-VOLTAREN 50 mg comprimidos dispersables 50mg Orodispersible 177

178 Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain VOLTAREN RETARD 75 mg comprimidos de liberación modificada 75mg Modified-release Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain VOLTAREN RETARD 100 mg comprimidos de liberación modificada 100mg Modified-release Spain NOVARTIS FARMACEUTICA, S.A. Gran Vía de les Corts Catalanes, Barcelona Spain VOLTAREN 75 mg/3 ml solución inyectable 75mg/3ml Solution for Intramuscular use Spain LABORATORIOS ALDO-UNION, S.A. Baronesa de Malda, Esplugues de Llobregat (Barcelona) Spain DICLOFENACO ALDO-UNION comprimidos EFG 50mg Tablet 178

179 Spain BEXAL FARMACEUTICA, S.A. Centro Empresarial Osa Mayor Avda. Osa Mayor, 4 - Area B Aravaca (Madrid) Spain DICLOFENACO BEXAL 50 mg comprimidos gastrorresistentes EFG 50mg Gastro-resistant Spain LABORATORIOS STADA, S.L Frederic Mompou, Sant Just Desvern (Barcelona) Spain DICLOFENACO RETARD STADA 100 mg comprimidos EFG 100mg Film-coated Spain LABORATORIOS STADA, S.L Frederic Mompou, Sant Just Desvern (Barcelona) Spain DICLOFENACO STADA 50 mg comprimidos EFG 50mg Gastro-resistant Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, Tres Cantos (Madrid) Spain DICLOFENACO NORMON 50 mg comprimidos dispersables EFG 50mg Orodispersible Spain LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, Tres Cantos (Madrid) Spain DICLOFENACO NORMON 50 mg comprimidos entéricos EFG 50mg Gastro-resistant 179

180 Spain Spain Spain Spain Spain FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) Spain FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) Spain FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) Spain FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) Spain FAES FARMA, S.A. Maximo Aguirre, Lamiaco-Lejona (Vizcaya) Spain DOLOTREN 50 mg comprimidos gastrorresistentes 50mg Gastro-resistant DOLOTREN RETARD 100mg Modified-release 100 mg cápsulas hard capsule duras de liberación prolongada DOLOTREN 50mg Orodispersible DISPERSABLE comprimidos DOLOTREN 100mg Suppository Rectal use supositorios DOLOTREN ampollas 75mg/3ml Solution for Intramuscular use 180

181 Spain SIGMA TAU ESPAÑA, S.A. Bolivia, 15 Polígono Industrial Azque Alcalá de Henares (Madrid) Spain LUASE 50 mg comprimidos 50mg Gastro-resistant Spain LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, Barcelona Spain DICLOFENACO LLORENS 50 mg comprimidos entéricos EFG 50mg Gastro-resistant Spain LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, Barcelona Spain DICLOFENACO LLORENS 75 mg solución inyectable EFG 75mg/3ml Solution for Intramuscular use Spain LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, Barcelona Spain DI-RETARD 100 mg comprimidos de liberación modificada 100mg Modified-release Spain LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, Barcelona Spain DICLOFENACO LLORENS 100 mg supositorios EFG 100mg Suppository Rectal use Spain RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D 5ª planta Madrid Spain DICLOFENACO RATIOPHARM 50 mg comprimidos 50mg Coated 181

182 Spain LABORATORIOS ALTER, S.A. Mateo Inurria, Madrid Spain DICLOFENACO ALTER 50 mg comprimidos EFG 50mg Gastro-resistant Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos Valencia Spain DICLOFENACO PENSA 50 mg comprimidos EFG 50mg Gastro-resistant Spain LABORATORIOS CINFA, S.A. Olaz-Chipi, 10 Polígono Industrial Areta Huarte-Pamplona (Navarra) Spain DICLOFENACO CINFA 50 mg comprimidos gastrorresistentes EFG 50mg Gastro-resistant Spain SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca (Madrid) Spain DICLOFENACO SANDOZ 50 mg comprimidos gastrorresistentes EFG 50mg Gastro-resistant Spain SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca (Madrid) Spain DICLOFENACO SANDOZ 100 mg supositorios EFG 100mg Suppository Rectal use 182

183 Spain SANDOZ FARMACEUTICA, S.A. Avda. Osa Mayor, Aravaca (Madrid) Spain DICLOFENACO SANDOZ RETARD 100 mg comprimidos de liberación modificada EFG 100mg Modified-release Spain LABORATORIOS RANBAXY, S.L. Passeig de Gracia, Barcelona Spain DICLOFENACO MUNDOGEN 50 mg comprimidos EFG 50mg Gastro-resistant Spain GERMED FARMACEUTICA, S.L. Chile, 8-2ª planta. Oficina Las Matas (Madrid) Spain DICLOFENACO EDIGEN 50 mg comprimidos EFG 50mg Gastro-resistant Spain Pfizer S.L. Avda. de Europa, 20 B Parque Empresarial La Moraleja Alcobendas (Madrid) Spain Misoprostol ARTROTEC 50mg 0,2mg Film-coated Spain Pfizer S.L. Avda. de Europa, 20 B Parque Empresarial La Moraleja Alcobendas (Madrid) Spain Misoprostol NORMULEN 50mg 0,2mg Film-coated Sweden Novartis Sverige AB Box Täby Sweden Voltaren 25mg Gastro-resistant 183

184 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Voltaren 50mg Gastro-resistant Diclofenac potassium Voltaren T 12,5mg Film-coated Voltaren 25mg/ml Solution for Parenteral use Diclofenac potassium Voltaren T 25mg Coated Diclofenac potassium Voltaren T 50mg Coated Diclofenac potassium Voltaren T 12,5mg Capsule, soft Diclofenac potassium Voltaren T 25mg Capsule, soft 184

185 Sweden Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Diklofenak Mylan 25mg Gastro-resistant Sweden Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Diklofenak Mylan 50mg Gastro-resistant Sweden Pfizer AB Vetenskapsvägen Sollentuna Sweden Diclofenac Misoprostol Arthrotec 50mg 0,2mg Modified-release Sweden Pfizer AB Vetenskapsvägen Sollentuna Sweden Diclofenac natrium Misoprostol Arthrotec forte 75mg 0.2mg Modified-release Sweden Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Diklofenak Sandoz 25mg Gastro-resistant Sweden Sandoz GmbH Biochemiestraße 10 Kundl A-6250 Diklofenak Sandoz 50mg Gastro-resistant 185

186 Sweden Sweden Sweden Sweden Sweden Sweden Sweden ratiopharm GmbH Graf Arco Strasse 3 D Ulm ratiopharm GmbH Graf Arco Strasse 3 D Ulm Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Meda OTC AB Östermalmsgatan Stockholm Sweden Evolan Pharma AB Box: Danderyd Sweden Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Diclofenac potassium Diclofenac T ratiopharm 25mg Film-coated Diclofenac potassium Diclofenac T 50mg Film-coated ratiopharm Diklofenak Orifarm 25mg Gastro-resistant Diklofenak Orifarm 50mg Gastro-resistant Diclofenac potassium Eeze 25mg Film-coated Diclofenac potassium Diklofenak T Evolan 50mg Film-coated Diklofenak T Orifarm 25mg Film-coated 186

187 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Orifarm Generics A/S PO 69, Energivej 15 DK-5260 Odense S Denmark Actavis A/S Ornegardsvej Gentofte Denmark Actavis A/S Ornegardsvej Gentofte Denmark Meda OTC AB Östermalmsgatan Stockholm Sweden Meda OTC AB Östermalmsgatan Stockholm Sweden Orion Corporation Orionintie 1 FI Espoo Finland Meda OTC AB Östermalmsgatan Stockholm Sweden Diklofenak T Orifarm 50mg Film-coated Diclofenac potassium Diklofenak T Actavis 25mg Film-coated Diclofenac potassium Diklofenak T Actavis 50mg Film-coated Diclofenac BMM 25mg Gastro-resistant Pharma Diclofenac BMM 50mg Gastro-resistant Pharma Diclofenac potassium Instantin 50mg Powder for oral solution Diclofenac potassium Eezeneo 25mg Film-coated 187

188 Sweden Sweden Sweden Sweden Sweden Sweden Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Vitabalans OY Varastokatu 8 FI Hämeenlinna Finland Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Diclofenac potassium Eezeneo 50mg Film-coated Diclofenac potassium Eeze 12,5mg Film-coated Diclofenac potassium Dicuno 25mg Film-coated Diclofenac potassium Dicuno 50mg Film-coated Diclofenac potassium Diklotab 25mg Film-coated Diclofenac potassium Diklotab 50mg Film-coated Diclofenac potassium Diklok 25mg Film-coated 188

189 Sweden Sweden Sweden Sweden Sweden Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Mimer Medical Svärdvägen 3B SE Danderyd Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Novartis Sverige AB Box Täby Sweden Diclofenac potassium Diklok 50mg Film-coated Diclofenac potassium Kappadi 25mg Film-coated Diclofenac potassium Kappadi 50mg Film-coated Voltaren 100mg Suppository Rectal use Voltaren 50mg Suppository Rectal use Voltaren 25mg Suppository Rectal use 189

190 Sweden Sweden Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Mylan AB PO Ynglingagatan 14 SE Stockholm Sweden Actavis B.V. Baarnsche Dijk LN Baarn Actavis B.V. Baarnsche Dijk LN Baarn Actavis B.V. Baarnsche Dijk LN Baarn Actavis B.V. Baarnsche Dijk LN Baarn Diklofenak Mylan 100mg Suppository Rectal use Diklofenak Mylan 50mg Suppository Rectal use Diclofenacnatrium 25mg Gastro-resistant Actavis 25 mg, maagsapresistente ten Diclofenacnatrium 50mg Gastro-resistant Actavis 50 mg, maagsapresistente ten Diclofenacnatrium 75mg Modified-release Actavis Retard 75 mg, ten met gereguleerde afgifte Diclofenacnatrium 100mg Modified-release Actavis Retard 100 mg, ten met gereguleerde afgifte 190

191 Actavis B.V. Baarnsche Dijk LN Baarn Diclofenacnatrium Actavis 25 mg, zetpillen 25mg Suppository Rectal use Actavis B.V. Baarnsche Dijk LN Baarn Diclofenacnatrium Actavis 50 mg, zetpillen 50mg Suppository Rectal use Actavis B.V. Baarnsche Dijk LN Baarn Diclofenacnatrium Actavis 100 mg, zetpillen 100mg Suppository Rectal use Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Diclofenac potassium Diclofenac Kalium Actavis 12,5 mg, filmomhulde ten 12,5mg Film-coated Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) Diclofenac potassium Eminocs 50 mg/ml, drank 50mg Oral drops, solution Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex 25 mg, maagsapresistente ten 25mg Gastro-resistant Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex 50 mg, maagsapresistente ten 50mg Gastro-resistant 191

192 Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex retard 100 mg, ten met gereguleerde afgifte 100mg Modified-release Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex 25 mg, zetpillen 25mg Suppository Rectal use Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex 50 mg, zetpillen 50mg Suppository Rectal use Apotex Europe B.V. Darwinweg CR Leiden Diclofenacnatrium Apotex 100 mg, zetpillen 100mg Suppository Rectal use Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na CF 25 mg/ml, oplossing voor injectie 25mg/ml Solution for Intramuscular use, Intravenous use Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na CF 25 mg, maagsapresistente ten 25mg Gastro-resistant Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na CF 50 mg, maagsapresistente ten 50mg Gastro-resistant 192

193 Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na zetpil CF 50 mg, zetpillen 50mg Suppository Rectal use Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na zetpil CF 100 mg, zetpillen 100mg Suppository Rectal use Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na retard CF 75 mg, ten met gereguleerde afgifte 75mg Modified-release Centrafarm B.V. Nieuwe Donk AC Etten Leur Diclofenac Na retard CF 100 mg, ten met gereguleerde afgifte 100mg Modified-release Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar EC 25, maagsapresistente ten 25 mg 25mg Gastro-resistant Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar EC 50, maagsapresistente ten 50 mg 50mg Gastro-resistant 193

194 Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar Retard 75, ten met gereguleerde afgifte 75 mg 75mg Modified-release Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar Retard 100, ten met gereguleerde afgifte 100 mg 100mg Modified-release Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar 25, zetpillen 25 mg 25mg Suppository Rectal use Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar 50, zetpillen 50 mg 50mg Suppository Rectal use Disphar International B.V. Winkelskamp PZ Hengelo Diclofenacnatrium Disphar 100, zetpillen 100 mg 100mg Suppository Rectal use Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent Diclofenacnatrium Manston 25 mg, maagsapresistente ten 25mg Gastro-resistant 194

195 Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent Diclofenacnatrium Manston 50 mg, maagsapresistente ten 50mg Gastro-resistant Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent Diclofenacnatrium retard Manston 100 mg, maagsapresistente ten 100mg Gastro-resistant Marel B.V. Archimedesweg CN Leiden Diclofenac potassium Kruidvat Diclofenac kalium 12,5 mg, filmomhulde ten 12,5mg Film-coated Mylan B.V. Dieselweg LB Bunschoten Diclofenacnatrium 50 mg, zetpillen 50mg Suppository Rectal use Mylan B.V. Dieselweg LB Bunschoten Diclofenacnatrium 100 mg, zetpillen 100mg Suppository Rectal use Novartis Consumer Health B.V. Claudius Prinselaan CP Breda Diclofenac potassium Voltaren K 12,5 mg, filmomhulde ten 12,5mg Film-coated 195

196 Novartis Consumer Health B.V. Claudius Prinselaan CP Breda Diclofenac potassium Voltaren K 25 mg, omhulde ten 25mg Coated Novartis Consumer Health B.V. Claudius Prinselaan CP Breda Diclofenac potassium Otriflu, omhulde ten 12,5 mg 12,5mg Coated Novartis Pharma B.V. Raapopseweg DP Arnhem Voltaren 25 mg, maagsapresistente ten 25mg Gastro-resistant Novartis Pharma B.V. Raapopseweg DP Arnhem Voltaren 75 mg/3 ml, oplossing voor injectie 25 mg/ml 25mg/ml Solution for Intramuscular use, Intravenous use Novartis Pharma B.V. Raapopseweg DP Arnhem Diclofenac potassium Cataflam 50, omhulde ten 50 mg 50mg Coated Novartis Pharma B.V. Raapopseweg DP Arnhem Voltaren Retard 75 mg, ten met verlengde afgifte 75mg Prolonged-release Pfizer B.V. Rivium Westlaan LD Capelle aan den IJssel Misoprostol Arthrotec 50, ten 50mg Modified-release 196

197 Pfizer B.V. Rivium Westlaan LD Capelle aan den IJssel Misoprostol Arthrotec 75, ten 75 mg 75mg Modified-release Pharmachemie B.V. Swensweg GA Haarlem Diclofenacnatrium 25 PCH, maagsapresistente ten 25mg Gastro-resistant Pharmachemie B.V. Swensweg GA Haarlem Diclofenacnatrium 50 PCH, maagsapresistente ten 50mg Gastro-resistant Pharmachemie B.V. Swensweg GA Haarlem Diclofenacnatrium 25 PCH, zetpillen 25 mg 25mg Suppository Rectal use Pharmachemie B.V. Swensweg GA Haarlem Diclofenacnatrium 50 PCH, zetpillen 50 mg 50mg Suppository Rectal use Pharmachemie B.V. Swensweg GA Haarlem Diclofenacnatrium 100 PCH, zetpillen 100 mg 100mg Suppository Rectal use Pharmachemie B.V. Swensweg GA Haarlem Diclofenac Na retard 75 PCH, ten met gereguleerde afgifte 75 mg 75mg Modified-release 197

198 Pharmachemie B.V. Swensweg GA Haarlem Diclofenac Na Retard 100 PCH ten met gereguleerde afgifte 100 mg 100mg Modified-release Pharmacin B.V. Molenvliet LH Zwijndrecht Diclofenacnatrium Pharmacin 25 mg, maagsapresistente ten 25mg Gastro-resistant Pharmacin B.V. Molenvliet LH Zwijndrecht Diclofenacnatrium Pharmacin 50 mg, maagsapresistente ten 50mg Gastro-resistant Pharmacin B.V. Molenvliet LH Zwijndrecht Diclofenac Na Pharmacin 100 mg, ten met gereguleerde afgifte 100mg Modified-release ratiopharm Nederland B.V. Florapark HK Haarlem Diclofenac Na ratiopharm retard 75 mg, ten met gereguleerde afgifte 75mg Modified-release Sandoz B.V. Veluwezoom AH Almere Diclofenacnatrium Sandoz retard 75, ten met gereguleerde afgite 75 mg 75mg Modified-release 198

199 Sandoz B.V. Veluwezoom AH Almere Diclofenacnatrium Sandoz retard 100, ten met gereguleerde afgite 100 mg 100mg Modified-release Sandoz B.V. Veluwezoom AH Almere Diclofenacnatrium Sandoz 25, maagsapresistente ten 25 mg 25mg Gastro-resistant Sandoz B.V. Veluwezoom AH Almere Diclofenacnatrium Sandoz 50, maagsapresistente ten 50 mg 50mg Gastro-resistant Sandoz B.V. Veluwezoom AH Almere Diclofenacnatrium Sandoz injectie 75 mg/3 ml, oplossing voor injectie 25 mg/ml 25mg/ml Solution for Intramuscular use, Intravenous use Teva Nederland B.V. Swensweg GA Haarlem Diclofenacnatrium 25 mg Teva, zetpilen 25mg Suppository Rectal use Teva Nederland B.V. Swensweg GA Haarlem Diclofenacnatrium 50 mg Teva, zetpilen 50mg Suppository Rectal use 199

200 Teva Nederland B.V. Swensweg GA Haarlem Diclofenacnatrium 100 mg Teva, zetpilen 100mg Suppository Rectal use Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester Diclofenacnatrium 25 mg, maagsapresistente ten 25mg Gastro-resistant Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester Diclofenacnatrium 50 mg, maagsapresistente ten 50mg Gastro-resistant Novartis Consumer Health UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL Diclofenac potassium Voltarol Pain-Eze Extra Strength Tablets 25mg Coated Novartis Consumer Health UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey GU15 3YL Diclofenac potassium Voltarol Pain-Eze Tablets 12,5mg Coated 200

201 Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Arthrotec 50 Modified-Release s 50mg Modified-release Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Arthrotec 75 Modified-Release s 75mg Modified-release Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Injection 75mg/3ml 75mg Solution for Injection Intramuscular use, Intravenous use Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Diclofenac free acid Voltarol Dispersible Tablets 50mg 46,5mg Tablet for oral solution Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Retard Tablets 100mg 100mg Modified-release 201

202 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 Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol SR Tablets 75mg Modified-release Voltarol 12,5mg Suppository Rectal use Suppositories 12.5mg Voltarol 25mg Suppository Rectal use Suppositories 25mg Voltarol 50mg Suppository Rectal use Suppositories 50mg Voltarol 100mg Suppository Rectal use Suppositories 100mg 202

203 Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Tablets 25mg 25mg Gastro-resistant Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Tablets 50mg 50mg Gastro-resistant Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Rapid Tablets 25mg 25mg Coated Novartis Pharmaceuticals UK ltd. Frimley, Camberley Surrey GU16 7SR Voltarol Rapid Tablets 50mg 50mg Coated Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS Flamatak MR Tablets 75mg 75mg Modified-release 203

204 Teva UK Limited Brampton Road Hampden Park Eastbourne E Sussex BN22 9AG Teva UK Diclofenac Sodium Tablets 25mg 25mg Gastro-resistant Teva UK Limited Brampton Road Hampden Park Eastbourne E Sussex BN22 9AG Teva UK Diclofenac Sodium Tablets 50mg 50mg Gastro-resistant Chatfield Pharmaceuticals Limited Kramer Mews London SW5 9JL Chatfield Pharms Diclofenac Sodium Tablets 25mg 25mg Gastro-resistant Mercury Pharma International Limited 4045 Kingswood Road City West Business Park Co Dublin, Ireland Antigen Diclofenac Sodium Injection 2.5% w/v 75mg Solution for Intramuscular use Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Sandoz Ltd Rhumalgan CR75 Modified Release Tablets 75mg 75mg Modified-release 204

205 Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Sandoz Ltd Rhumalgan CR100 Modified Release Tablet 100mg 100mg Modified-release Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Lagap Pharms Diclofenac Tablets 25mg 25mg Gastro-resistant Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Lagap Pharms Diclofenac Tablets 50mg 50mg Gastro-resistant Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Sandoz Ltd Diclovol SR Modified Release Tablet 75 mg 75mg Modified-release Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Sandoz Ltd Rhumalgan SR Modified Release Capsules 75mg 75mg Modified-Release Capsule, Hard 205

206 Sandoz Limited Frimley Business Park Frimley Camberley, GUI16 7SR Sandoz Ltd Rhumalgan XL Modified Release Capsules 100mg 100mg Modified-Release Capsule, Hard Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Generics UK Diclofenac Sodium Tablets 25mg 25mg Gastro-resistant Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL Generics UK Diclofenac Sodium Tablets 50mg 50mg Gastro-resistant Waymade Plc Regency House Miles Gray Road Basildon, Essex SS14 3RF Rheumatac Retard Tablets 75mg 75mg Modified-release Daichi-Sankyo UK Limited Chiltern Place Chalfont Park Gerrards Cross Buckinghamshire SL9 0BG Motifene Capsules 75mg 75mg Modified-release capsule 206

207 Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY Volsaid Retard Tablets 75mg 75mg Modified-release Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY Volsaid Retard Tablets 100mg 100mg Modified-release Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Econac Suppositories 100mg 100mg Suppository Rectal use Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Econac Injection 75mg/3ml 75mg Solution for Intramuscular use Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Mercury Pharms Diclofenac Solution for Injection 75mg/3ml 75mg Solution for Intramuscular use, Intravenous use 207

208 Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Mercury Pharma Group Limited No. 1 Croydon Addiscombe Road Croydon, Surrey CR0 0XT Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS Mercury Pharms Econac SR Prolonged Release Tablet 75mg 75mg Prolonged-release Mercury Pharms 100mg Prolonged-release Econac XL Prolonged Release Tablet 100mg Mercury Pharms 25mg Tablet Diclofenac Sodium Tablets 25mg Mercury Pharms 50mg Tablet Diclofenac Sodium Tablets 75mg Diclo-XL mg Modified-release 208

209 Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS Diclo-SR 75 75mg Modified-release Dexcel Pharma Limited 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB Dexcel-Pharma Dicloflex Retard Prolonged Release Tablet 100mg 100mg Modified-release Dexcel Pharma Limited 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB Dexcel-Pharma Dicloflex SR Prolonged Release Tablet 75mg 75mg Modified-release Dexcel Pharma Limited 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB Dexcel-Pharma Diclofenac Sodium Tablets 25mg 25mg Gastro-resistant 209

210 Dexcel Pharma Limited 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB Dexcel-Pharma Diclofenac Sodium Tablets 75mg 75mg Gastro-resistant Bristol Laboratories Limited Unit 3, Canal side Northbridge Road,Berkhamsted Hertfordshire HP4 1EG Volraman 25mg Gastro-resistant s 25mg Gastro-resistant Bristol Laboratories Limited Unit 3, Canal side Northbridge Road,Berkhamsted Hertfordshire HP4 1EG Volraman 50mg Gastro-resistant s 50mg Gastro-resistant Focus Pharmaceuticals Limited Unit 5, Faraday court First Avenue,Centrum 100 Burton upon trent Staffordshire, DE14 2WX Diclofenac potassium Adacium Rapid 50mg Tablets 50mg Film-coated Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Misoprostol Misofen 50mg/200mcg modified released s 50mg 0,2mg Modified-release 210

211 Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA Misoprostol Misofen 75mg/200mcg modified released s 75mg 0.2mg Modified-release Crescent Pharma Limited Unit 3&4 Quidhampton Business Units Polhampton Lane, Overton Hampshire, RG25 3ED Diclofenac Crescent Pharma Diclofenac Tablets BP 25mg 25mg Gastro-resistant Crescent Pharma Limited Unit 3&4 Quidhampton Business Units Polhampton Lane, Overton Hampshire, RG25 3ED Diclofenac Crescent Pharma Diclofenac Tablets BP 50mg 50mg Gastro-resistant Therabel pharma UK Limited Compass House, vision Park Chivers, Histon Cambridge CB24 9AD Dyloject 75mg/2ml solution for 75mg/2ml solution for Intramuscular use, Intravenous use Galen Limited Seagoe Industrial Estate Craigavon Armagh BT 63 5AU Diclomax SR 75mg Modified-release capsule 211

212 Galen Limited Seagoe Industrial Estate Craigavon Armagh BT 63 5AU Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Actavis Group PTC ehf Reykjavikurvegi IS-220 Hafnarfjördur Iceæand Chelonia Healthcare Limited Boumpoulinas 11 3rd, Nicosia CY-1060 Cyprus Diclomax Retard 100mg Modified-release capsule Diclofenac potassium Doble action pain 12,5mg Tablet relief Diclofenac potassium Diclofenac potassium 12,5mg Tablet 12.5mg Tablets Diclofenac potassium Diclofenac potassium 25mg Film-coated 25mg Tablets Diclofenac potassium Diclofenac potassium 50mg Film-coated 50mg Tablets 25mg Gastro-resistant 25mg Tablets 212

213 RI Pharma Limited First floor,6 St John's Court Upper Fforest Way Swansea Enterprise Park Swansea SA6 8QQ RI Pharma Limited First floor,6 St John's Court Upper Fforest Way Swansea Enterprise Park Swansea SA6 8QQ Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS Aptil Pharma limited 9th Floor CP House Uxbridge Road London W5 5TL Slofenac 75mg SR 75mg Modified-release Slofenac 100mg SR 100mg Modified-release Enstar SR 75mg 75mg Prolonged-release Tablets Enstar XL 100mg 100mg Modified-release Tablets Diclofenac potassium Diclofenac potassium 12,5mg Film-coated 12.5mg Tablets 213

214 Aptil Pharma limited 9th Floor CP House Uxbridge Road London W5 5TL Diclofenac potassium Diclofenac potassium 25mg Tablets 25mg Film-coated Aptil Pharma limited 9th Floor CP House Uxbridge Road London W5 5TL Diclofenac potassium Diclofenac potassium 50mg Tablets 50mg Film-coated 214

215 Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations 215

216 Scientific conclusions The CMDh, having considered the PRAC recommendation dated 13 June 2013 with regards to diclofenac containing medicinal products (systemic formulations), agrees with the recommendation therein as stated below: Overall summary of the scientific evaluation of diclofenac containing medicinal products (systemic formulations) (see Annex I) Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs, such as diclofenac, are indicated in the relief of all grades of pain and inflammation associated with a wide range of conditions, including arthritic conditions, acute musculo-skeletal disorders and other painful conditions resulting from trauma. Diclofenac containing medicinal products (systemic formulations) are available as s, capsules for oral, suppositories for rectal and solutions for intravenous or intramuscular. Epidemiological and clinical trial data on the cardiovascular risks of NSAIDs, including diclofenac, were previously reviewed by the Committee for Medicinal Products for Human Use (CHMP). In 2006 it was concluded that a small increase in the absolute risk of thrombotic events could not be excluded for NSAIDs as a class, especially when used at high-doses and long-term therapy, although the risk was considered to be higher for the selective cyclooxygenase-2 (Cox-2) inhibitors (also known as coxibs) compared to NSAIDs. Risk minimisation measures (in the form of contraindications and warnings in the product information) were implemented at the time for Cox-2 inhibitors. The data available (in particular data from the MEDAL 1 programme) suggested that the risk of arterial thrombotic events with diclofenac was similar to that for coxibs, but firm conclusions could not be drawn and further epidemiological studies were needed to obtain additional data. Another evaluation conducted by the CHMP in considered all available published evidence to date from meta-analysis of clinical trials and observational studies, and also epidemiological studies. Results of the safety of non-steroidal anti-inflammatory drugs (SOS) research project funded by the European Commission under the Seventh Framework Programme were considered in the review that concluded that available evidence regarding diclofenac seemed to consistently point towards a less favourable cardiovascular risk profile compared to other NSAIDs, and similar risks as those of Cox-2 inhibitors. A new review was considered necessary and was initiated to address the cardiovascular safety concerns for diclofenac and their impact on the benefit-risk balance of diclofenac containing medicinal products (systemic formulations). This review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC acknowledged the conclusions of previous reviews with regards to the cardiovascular safety of diclofenac. Data provided by the MAHs in writing and at an oral explanation and relevant data made available by independent researchers were also considered. The PRAC concluded that diclofenac is effective in reducing inflammation and pain. Recognised risks associated with NSAID treatment in general, and with diclofenac treatment in particular, include serious gastrointestinal effects including PUB (perforation, ulcer, bleeding), cardio-renal effects, hepatic effects and skin reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis). These are appropriately reflected in the product information. With regards to cardiovascular risks, the PRAC noted that the initial signal from the MEDAL programme was confirmed by the meta-analyses of randomised clinical trials conducted by Trelle et al (2011) and Chen and Ashcroft (2007). Meta-analyses of observational data and individual observational studies also consistently indicated that diclofenac is associated with a similar level of risk as Cox-2 inhibitors. An increased risk with diclofenac was also observed in the SOS nested-cases control studies across all databases and for both myocardial infarction and ischaemic stroke. Schjerning Olsen et al (2011) provided data on risks in relation to duration of exposure and found that the risks associated with diclofenac were very similar to those of coxibs at all time points. The new evidence provided by marketing authorisation s including evidence from new casecontrol studies and retrospective studies add to the evidence of an increased risk with diclofenac 1 For more details on the MEDAL programme, including its components, please refer to the assessment report for the review conducted in 2006 at 2 For more information on the review conducted in 2012, please refer to the assessment report for the procedure at 216

217 compared to other NSAIDs and that the risk with diclofenac is similar to that of coxibs. The study by Krum et al 2012, a post hoc analysis of the MEDAL trial, showed that there was no significant differential effect between etoricoxib and diclofenac in relation to cardiovascular events, except for confirmed congestive heart failure. Evidence available from a new meta-analysis of randomised clinical trials conducted by an independent research group was included in the review. The study, which looked at more than 600 randomised clinical trials, concluded that the vascular risks of high dose diclofenac are comparable to Cox-2 inhibitors. Major vascular events were increased by about one third by a coxib (rate ratio [RR] 1.37, 95% confidence interval [CI] ; p=0.0009) or diclofenac (1.41, ; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, ; p=0.0001; diclofenac: 1.70, ; p=0.0032). The data available today do not allow conclusion on the specific mechanisms underlying the cardiovascular thrombotic risks of diclofenac, although several studies have explored different options and it can be noted that is unlikely that one single mechanism would explain the risk. Considering that an increased cardiovascular risk with diclofenac is observed, and this appears similar to that of selective Cox-2 inhibitors, it therefore follows that any risk minimisation in place for Cox-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac. The PRAC therefore recommended an amendment to the product information for diclofenac to include an updated contraindication in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. In addition, patients with certain cardiovascular risk factors (such as hypertension, hyperlipidaemia, diabetes mellitus or smoking) should only use diclofenac after careful consideration and therefore the warnings should also be updated to reflect this. Moreover, the general rule that NSAIDs should be used at the lowest dose for the shortest duration possible should be consistently implemented in the posology section of the product information. Furthermore, a proactive communication of these new measures through a direct healthcare professional communication (DHPC) was recommended. The PRAC considered that the recommendation for update of the product information should be applicable to all medicinal products containing diclofenac (systemic formulations), regardless of dose. The available information on the dose effect of diclofenac is limited. Although the data point towards a dose dependent effect on thrombotic risk associated with the use of diclofenac, particularly at high dose, it is difficult to establish a clear cut-off dose above which the risks become significantly increased. Some studies also report an association with lower doses. Based on the available data to date, the PRAC therefore concluded that the cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities. Benefit/risk balance Having noted all of the above, the PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a DHPC letter. 217

218 Grounds for PRAC recommendation Whereas, The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diclofenac containing medicinal products (systemic formulations). The PRAC considered the totality of the data available in relation to the cardiovascular safety of diclofenac containing medicinal products, acknowledging the conclusions from previous reviews by the CHMP, the submissions by marketing authorisation s in writing and at an oral explanation, and emerging data from independent researchers. The PRAC considered that with regards to the arterial thrombotic risks of diclofenac, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, allow the conclusion that diclofenac is associated with increased cardiovascular risks. It was observed that these are similar to those of selective Cox-2 inhibitors. The PRAC considered that diclofenac containing medicinal products are effective in their approved indications. The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. In addition, patients with certain cardiovascular risk factors (hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should only use diclofenac after careful consideration and therefore the warnings should be updated to reflect this. Moreover, the general rule that NSAIDs should be used at the lowest dose for the shortest duration possible should be consistently implemented in the posology section of the product information. The PRAC also concluded that there was need for further risk minimisation measures such as information to healthcare professionals. Key elements for a direct healthcare professional communication were agreed, together with the timelines for distribution. The PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a communication letter. Therefore in accordance with Articles 31 and 32 of Directive 2001/83/EC, the PRAC recommends the variation of the marketing authorisations for all medicinal products referred to in Annex I and for which the amendments to the product information are set out in annex III of the recommendation. CMDh position The CMDh, having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diclofenac containing medicinal products for which the amendments to the product information are set out in annex III. 218

219 Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet Note: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure. The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 219

220 A. Summary of Product Characteristics Section 4.2 Posology and method of : [The wording below should be inserted in this section] [ ] Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). Section 4.3 Contraindications: [The wording below should be inserted in this section] [ ] Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. [ ] Section 4.4 Special warnings and precautions for use: [The wording below should be inserted in this section] [ ] Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. [ ] Section 4.8 Undesirable effects: [The wording below should be inserted in this section] [ ] Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment. (see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions for use). [ ] B. Package Leaflet Section 2 What you need to know before you take <diclofenac containing medicinal product> [The wording below should be inserted in the relevant sections] [ ] Do not use diclofenac if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages if you have or have had problems with your blood circulation (peripheral arterial disease) Make sure your doctor knows, before you are given diclofenac If you smoke If you have diabetes If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides Side effects may be minimised by using the lowest effective dose for the shortest duration necessary. [ ] 220