EN Official Journal of the European Union C 316/48

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2007 to 30 November 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )

(2007/C 316/06)

— 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 19.11.2007 Tasigna Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom This Decision is addressed to the Member States 20.11.2007 22.11.2007 Bicaluplex See Annex I See Annex I 23.11.2007

(Decisions taken pursuant to Article 107 of Directive 2001/83/EC)

— 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 30.11.2007 Clobutinol See Annex II See Annex II 3.12.2007

(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 FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing authorisation holder Applicant Name Strength Pharmaceutical form Route of administration Austria Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bicalutamid-TEVA 150 mg-Filmtabletten 150 mg Film-coated tablet Oral use Czech Republic Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicaluplex 150 mg 150 mg Film-coated tablet Oral use Germany Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicamid-GRY 150 mg Filmtabletten 150 mg Film-coated tablet Oral use Denmark TEVA Sweden AB PO Box 1070 S-25110 Helsingborg Bicalutamid TEVA 150 mg Film-coated tablet Oral use Estonia Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bicalutamide-TEVA 150 mg Film-coated tablet Oral use Greece TEVA Classics S.A. 1, cours du Triangle Immeuble Palatin 1 F-92936 Paris La Défense Cedex 12 Bicalutamide Teva 150 mg, comprimés pelliculés 150 mg Film-coated tablet Oral use France Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bicalutamide Teva 150 mg Επικαλυμμένα με λεπτό υμένιο δισκία 150 mg Film-coated tablet Oral use Hungary TEVA Magyarország Rt Rákóczi út 70-72 H-1074 Budapest Bicalutamid-Teva 150 mg Film-coated tablet Oral use Italy TEVA Pharma Italia S.R.L. Viale G. Richard 7 I-20143 Milano Bicalutamide TEVA 150 mg compresse rivestite con film 150 mg Film-coated tablet Oral use Latvia Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bicalutamide-TEVA 150 mg Film-coated tablet Oral use Lithuania Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bicalutamide-Teva 150 mg plėvele dengtos tabletės 150 mg Film-coated tablet Oral use The Netherlands Pharmachemie B.V. Swensweg 5 Postbus 552 2003 RN Haarlem Nederland Bicalutamide 150 PCH, filmomhulde tabletten 150 mg 150 mg Film-coated tablet Oral use Norway TEVA Sweden AB PO Box 1070 S-25110 Helsingborg Bicalutamid TEVA 150 mg tabletter, filmdrasjerte 150 mg Film-coated tablet Oral use Poland Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicalutamide Ingers 150 mg tabletki powlekane 150 mg Film-coated tablet Oral use Portugal TEVA Pharma — Produtos Farmacêuticos Lda Lagoas Park Edifício 1 Piso 3 P-2740-264 Porto Salvo Bicalutamida Teva 150 mg Film-coated tablet Oral use Slovakia Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicalutamid-Teva 150 mg 150 mg Film-coated tablet Oral use Slovenia Teva Pharma B.V. Industrieweg 23 P.O. Box 217 3640 AE Mijdrecht Nederland Bikalutamid TEVA 150 mg filmsko obložene tablete 150 mg Film-coated tablet Oral use Sweden Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicalutamide Teva 150 mg filmdragerade tabletter 150 mg Film-coated tablet Oral use The United Kingdom Ingers Industrial Solutions s. r. o. Jeneweinova 51a CZ-617 00 Brno Bicalutamide 150 mg Film-coated Tablets 150 mg Film-coated tablet Oral use