Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data
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1 29 November 2012 EMA/764460/2012 Patient Health Protection Annex I List of the names, pharmaceutical s, strengths of the medicinal products, routes of, marketing authorisation s in the member states for diacerin containing medicinal products Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data Procedure number: EMEA/H/A-31/ Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 TRB Chemedica () GmbH IZ NOE- Sued,Straße7,Obj.58D/1/2.OG 2355 Wiener Neudorf ARTROLYT 50 mg Kapseln TRB Chemedica () GmbH IZ NOE- Sued,Straße7,Obj.58D/1/2.OG 2355 Wiener Neudorf VERBORIL 50 mg Kapseln Czech Republic TRB Chemedica () GmbH IZ NOE- Sued,Straße7,Obj.58D/1/2.OG 2355 Wiener Neudorf NEGMA 10, rue Paul Dautier Vélizy Villacoublay ARTRODAR ART 50 mg, ACTAVIS GROUP (ISLANDE) Reykjavikurvegur Hafnarfjordur ISLANDE ACTAVIS 50 mg, ARROW GENERIQUES 26, avenue Tony Garnier Lyon ARROW 50 mg, EMA/764460/2012 Page 2/9
3 BIOGARAN 15, boulevard Charles de Gaulle Colombes BIOGARAN 50 mg, CRISTERS 22 quai Gallieni Suresnes CRISTERS 50 mg, EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou Boulogne Billancourt Cedex EVOLUGEN 50 mg, EVOLUPHARM rue Irène Caron Zone Industrielle d'auneuil Auneuil EVOLUGEN 50 mg, SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini Paris GENODEX 50 mg, MAZAL PHARMACEUTIQUE 11, rue Rontgen BP Quimper MAZAL 50 mg, EMA/764460/2012 Page 3/9
4 MYLAN SAS 117, allée des Parcs Saint-Priest MYLAN 50 mg, NEGMA 10, rue Paul Dautier Vélizy Villacoublay NEGMA 50 mg, LABORATOIRES PHARMA rue Paul Dautier Vélizy Villacoublay PHARMA mg, QUALIMED (LYON) 117, allée des Parcs Saint-Priest QUALIMED 50 mg, RANBAXY PHARMACIE GENERIQUES Quai Dion Bouton Puteaux RANBAXY 50 mg, TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex RATIOPHARM 50 mg, BIOGARAN 15, boulevard Charles de Gaulle C olombes REF 50 mg, EMA/764460/2012 Page 4/9
5 SANDOZ 49, avenue Georges Pompidou Levallois-Perret SANDOZ 50 mg, SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini Paris SUBSTILAB 50 mg, SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini Paris SUBSTIPHARM 50 mg, TEVA SANTE 110, Esplanade du Général de Gaulle Paris La Défense Cedex TEVA 50 mg, SANOFI AVENTIS 1-13, boulevard Romain Rolland Paris ZENTIVA 50 mg, ZYDUS 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d Activités des Peupliers Nanterre ZYDUS 50 mg, EMA/764460/2012 Page 5/9
6 MAZAL PHARMACEUTIQUE 11, rue Rontgen BP Quimper MAZART 50 mg, NIVERPHARM 10 rue Paul Dautier Vélizy Villacoublay ZONDAR 50 mg, ANGELINI PHARMA HELLAS Nea Kifissia 14564, Athens Genepharm a.e. 18th km Marathonos Avenue, Pallini, Attikis, VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674, Athens Rafarm Aebe Korinthou 12, Neo Psychiko, HELP ABEE Valaoritou 10, Metamorfosi, Attikis, VERBORIL ARTHROREIN ARTHROFAR IDEALITE INFLABION EMA/764460/2012 Page 6/9
7 BROS EPE Avgis & Gallinis 15, n. Kifissia, FARMEDIA A.E. Athinas 22 & Apollonos Gerakas, Attikis, GENEPHARM A.E. 18th km Marathonos Avenue, Pallini, Attikis, PHARMACEUTICAL INDUSTRY Proel Epam. G. Koronis Dilou 9, Peristeri, Attikis, NORMA HELLAS A.E. Menandrou 54, Athens, S.M. Pharmaceutical Products Ltd, Agiou Orous 43-45, Piraeus PROTON PHARMA Anonymous Pharmaceutical Company, Achaias 4 and Trizoinias, Nea Kifissia REUMANISAL OSTIREIN MYOBLOC DIACEREIN /PROEL DIACEREIN /NORMA DESEREIN DIACERIL EMA/764460/2012 Page 7/9
8 Italy Portugal Slovak Republic ABIOGEN PHARMA S.p.A. Via Meucci Ospedaletto Pisa Italy Neo-Farmacêutica, S.A. Av. D. João II, Lote D- 2º Lisboa Portugal TRB CHEMEDICA () GmbH, IZ NOE-Sued, Strasse 7, Obj.58D/1/2.OG, 2355 Wiener Neudorf, FISIODAR Artrolyt ARTRODAR ROTTAPHARM S.L. Avda. Diagonal, Barcelona GLIZOLAN 50 mg cápsulas NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F ARTRIZAN 50 mg cápsulas LACER S.A. Sardenya, Barcelona GALAXDAR 50 mg cápsulas EMA/764460/2012 Page 8/9
9 LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, Tres Cantos (Madrid) DIACEREINA NORMON 50 mg cápsulas duras EFG IBERMEDGEN S.A. Ronda de Valdecarrizo, Tres Cantos (Madrid) DIACEREINA PANLUETOL 50 mg cápsulas duras EFG MG PHARMA 8, Rue Bellini Paris REINART 50 mg cápsulas duras EFG EMA/764460/2012 Page 9/9
ARTROLYT 50 mg Kapseln. DIACEREINE ACTAVIS mg capsule, hard oral use
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