EN Official Journal of the European Union C 184/17

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2011/C 184/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 10.3.2011 Tienam and associated names See Annex I See Annex I 11.3.2011 17.3.2011 INOmax - II 19 INO Therapeutics AB, SE-181 81 Lidingö, Sverige These Decisions are addressed to the Member States 21.3.2011 18.3.2011 INOmax - X 21 INO Therapeutics AB, SE-181 81 Lidingö, Sverige These Decisions are addressed to the Member States 22.3.2011 14.3.2011 Repso Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland These Decisions are addressed to the Member States 16.3.2011 17.3.2011 GILENYA Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom These Decisions are addressed to the Member States 21.3.2011 28.3.2011 Trobalt Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom These Decisions are addressed to the Member States 29.3.2011 10.3.2011 Abseamed Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Deutschland These Decisions are addressed to the Member States 11.3.2011 10.3.2011 Leflunomide Teva Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland These Decisions are addressed to the Member States 11.3.2011 14.3.2011 Binocrit Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich These Decisions are addressed to the Member States 16.3.2011 14.4.2011 Brinavess Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom These Decisions are addressed to the Member States 15.4.2011 14.3.2011 Epoetin alfa Hexal Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland These Decisions are addressed to the Member States 17.3.2011





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 20.4.2011 morphine/oxycodone/hydromorphone See Annex II See Annex II 26.4.2011

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Merck Sharp & Dohme Ges.m.b.H. Am Euro Platz 2 1120 Wien Austria Zienam 500 mg Trockensubstanz zur Infusionsbereitung 500 mg Powder for solution for infusion Intravenous use Belgium Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 1180 Bruxelles Belgium Tienam 500 mg, poudre pour solution pour perfusion / Tienam Monovial 500 mg, poudre pour solution pour perfusion 500 mg/500 mg Powder for solution for infusion Intravenous use Bulgaria Merck Sharp & Dohme Bulgaria EOOD 55, Nikola Vaptzarov Blvd., Expo 2000 Sofia 1407 Bulgaria Tienam 500/500 mg powder for solution for infusion Тиенам 500/500 mg прах за инфузионен разтвор 500/500mg Powder for solution for infusion Intravenous use Czech Republic Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, The Netherlands Tienam i.v. 500mg /500mg i.v. 500 mg/500 mg Powder for solution for infusion Intravenous use Estonia Merck Sharp & Dohme OÜ Peterburi St 46, 11415 Tallinn Estonia TIENAM I.V. 500 MG/500 MG 500 mg/500 mg Powder for solution for infusion Intravenous use Finland Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, The Netherlands TIENAM 500 mg/500 mg Powder for solution for infusion Intravenous use France Merck Sharp & Dohme Chibret 3 avenue Hoche 75114 Paris cedex 08 France TIENAM 500 mg/500 mg, poudre pour perfusion avec système de transfert pour poche 500 mg/500 mg Powder for infusion Intravenous use France Merck Sharp & Dohme Chibret 3 avenue Hoche 75114 Paris cedex 08 France TIENAM 250 mg/250 mg, poudre pour perfusion 250 mg/250 mg Powder for infusion Intravenous use France Merck Sharp & Dohme Chibret 3 avenue Hoche 75114 Paris cedex 08 France TIENAM 500 mg/500 mg, poudre pour perfusion 500 mg/500 mg Powder for infusion Intravenous use France Merck Sharp & Dohme Chibret 3 avenue Hoche 75114 Paris cedex 08 France TIENAM 500 mg/500 mg, poudre et solution pour usage parentéral (IM) 500 mg/500 mg Powder for suspension for parenteral use (IM) Intramuscular use Germany MSD SHARP & DOHME GMBH Lindenplatz 1 D-85540 Haar Germany ZIENAMo 500 mg Pulver zur Herstellung einer Infusionslösung 500 mg/500 mg Powder for solution for infusion Intravenous use Greece Vianex S.A Tatoiou str. 18th Km Athens-Lamia National Road 14671 Nea Erythrea Greece Primaxin DR.PD.INJ (500+500)mg/Vial (IV) 500 mg Dry Powder for injection Intravenous use Greece Vianex S.A Tatoiou str. 18th Km Athens-Lamia National Road 14671 Nea Erythrea Greece Primaxin DR.PD.INJ (250+250mg/Vial (IV) 250mg Dry Powder for injection Intravenous use Hungary MSD Hungary Ltd. 1123 Budapest, Alkotás u. 50. Hungary Tienam 500 mg Powder for solution for infusion Intravenous infusion Iceland Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands Tienam 500 mg/500 mg Powder for solution for infusion Intravenous infusion Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Pelham House South County Business Park Leopardstown Dublin 18 Ireland Primaxin IV 500mg/500mg Powder for Solution for Infusion 500 mg/500 mg Powder for solution for infusion Intravenous infusion Italy Merck Sharp & Dohme (Italia) S.p.A. Via Vitorchiano, 151 – 00189 Roma Italy TIENAM (20 ml) 500 mg/500 mg Powder for solution for infusion Intravenous infusion Italy Merck Sharp & Dohme (Italia) S.p.A. Via Vitorchiano, 151 – 00189 Roma Italy IMIPEM (20 ml) 500 mg/500 mg Powder for solution for infusion Intravenous infusion Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A, Viale Shakespeare, 47 00144 Roma Italy TENACID (20 ml) 500 mg/500 mg Powder for solution for infusion Intravenous infusion Latvia SIA „Merck Sharp & Dohme Latvija“, Skanstes 13, Riga, LV-1013 Latvia TIENAM I.V. 500 mg/500 mg Powder for solution for infusion Intravenous use Lithuania Merck Sharp & Dohme, UAB, Kęstučio 59/27, LT-08124 Vilnius Lithuania TIENAM I.V. 500 mg + 500 mg Powder for solution for injection Intravenous use Luxembourg Merck Sharp & Dohme B.V. Chaussée de Waterloo 1135 1180 Bruxelles Belgium Tienam 500 mg, poudre pour solution pour perfusion / Tienam Monovial 500 mg, poudre pour solution pour perfusion 500 mg/500 mg Powder for solution for infusion Intravenous use Malta Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU United Kingdom Primaxin IV 500mg Injection 500mg Powder for concentrate for solution for infusion Intravenous use Netherlands Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem The Netherlands Tiënam I.V. 250 mg and 500 mg Powder for solution for infusion Intravenous use Norway Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands Tienam 500 mg/500 mg Powder for solution for infusion Intravenous use Poland MSD Polska Sp. z o.o. ul. Chłodna 51 00-867 Warszawa Poland TIENAM 500 mg/500 mg Powder for solution for infusion Intravenous use Portugal Merck Sharp & Dohme, Lda. Quinta da Fonte Edifício Vasco da Gama, 19 P.O. BOX 214 Porto Salvo 2770-192 Paço de Arcos Portugal Tienam IV 500 mg / 500 mg Powder for solution for infusion Intravenous use Romania Merck Sharp & Dohme Romania S.R.L. Bucharest Business Park, Șos. București-Ploiești Nr.1A, Clădirea C1, Etaj 3, Sector 1, București Romania TIENAM I.V., pulbere pentru soluție perfuzabilă 500 mg/500 mg Powder for solution for infusion Intravenous use Slovak Republic Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem P.O. Box 581, 2003 PC Haarlem The Netherlands TIENAM i.v. 500 mg/500 mg Powder for solution for infusion Intravenous use Slovenia Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140, 1000 Ljubljana, Slovenia CONET 500 mg/500 mg prašek za raztopino za infundiranje 500 mg/500 mg Powder for solution for infusion Intravenous use Spain Merck Sharp & Dohme de España, S.A. C/ Josefa Valcárcel, 38 28027 Madrid Spain TIENAM I.V. 500 mg powder for solution for infusion 500 mg/500 mg Powder for solution for infusion Intravenous use Sweden Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem, P.O.Box 581, 2003 PC Haarlem The Netherlands Tienam 500 mg/500 mg Powder for solution for infusion Intravenous use United Kingdom Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Herts, EN11 9BU United Kingdom PrimaxinIV 500mg Injection 500mg Powder for concentrate for solution for infusion Intravenous use