EN Official Journal of the European Union C 288/14

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 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 288/05)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 3.10.2007 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom This Decision is addressed to all Member States 5.10.2007 23.10.2007 Fentanyl Matrixplaster See Annex I See Annex I 26.10.2007 23.10.2007 Fentanyl TTS See Annex II See Annex II 26.10.2007 24.10.2007 Xeomin See Annex III See Annex III 25.10.2007

— Revocation 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 1.10.2007 Veralipride See Annex IV See Annex IV 3.10.2007

(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (Concentration) Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 25 μg/h Matrixpflaster 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 50 μg/h Matrixpflaster 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 75 μg/h Matrixpflaster 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 100 μg/h Matrixpflaster 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fentanyl-ratiopharm 25 μg/h transdermales Matrixpflaster 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fentanyl-ratiopharm 50 μg/h transdermales Matrixpflaster 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fentanyl-ratiopharm 75 μg/h transdermales Matrixpflaster 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fentanyl-ratiopharm 100 μg/h transdermales Matrixpflaster 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 25 μg/h, dispositif transdermique 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 50 μg/h, dispositif transdermique 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 75 μg/h, dispositif transdermique 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 100 μg/h, dispositif transdermique 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour The Netherlands ratiopharm Nederland bv Ronde Tocht 11 1507 CC Zaandam Nederland Fentanyl ratiopharm 25 μg/uur, pleister voor transdermaal gebruik 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour The Netherlands ratiopharm Nederland bv Ronde Tocht 11 1507 CC Zaandam Nederland Fentanyl ratiopharm 50 μg/uur, pleister voor transdermaal gebruik 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour The Netherlands ratiopharm Nederland bv Ronde Tocht 11 1507 CC Zaandam Nederland Fentanyl ratiopharm 75 μg/uur, pleister voor transdermaal gebruik 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour The Netherlands ratiopharm Nederland bv Ronde Tocht 11 1507 CC Zaandam Nederland Fentanyl ratiopharm 100 μg/uur, pleister voor transdermaal gebruik 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiopharm 25 microgramos/h parches transdérmicos EFG 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiopharm 50 microgramos/h parches transdérmicos EFG 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiopharm 75 microgramos/h parches transdérmicos EFG 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiopharm 100 microgramos/h parches transdérmicos EFG 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Telfanyl 25 microgram/hr Transdermal patch (pending) 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Telfanyl 50 microgram/hr Transdermal patch (pending) 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Telfanyl 75 microgram/hr Transdermal patch (pending) 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Telfanyl 100 microgram/hr Transdermal patch (pending) 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical form Route of administration Content (Concentration) Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 25 μg/h TTS 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 50 μg/h TTS 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 75 μg/h TTS 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Germany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratiopharm 100 μg/h TTS 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fenturogenox 25 μg/h — transdermales Matrixpflaster 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fenturogenox 50 μg/h — transdermales Matrixpflaster 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fenturogenox 75 μg/h — transdermales Matrixpflaster 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Austria ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 A-1140 Wien Fenturogenox 100 μg/h — transdermales Matrixpflaster 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratio 25 μg/h, dispositif transdermique 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratio 50 μg/h, dispositif transdermique 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratio 75 μg/h, dispositif transdermique 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour France ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl-ratio 100 μg/h, dispositif transdermique 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour The Netherlands ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 μg/uur 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour The Netherlands ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 μg/uur 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour The Netherlands ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 μg/uur 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour The Netherlands ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 μg/uur 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiomed 25 microgramos/h parches transdérmicos EFG 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiomed 50 microgramos/h parches transdérmicos EFG 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiomed 75 microgramos/h parches transdérmicos EFG 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour Spain ratiopharm España, S.A. Avenida de Burgos 16D 5o Planta E-28036 Madrid Fentanilo Matrix ratiomed 100 microgramos/h parches transdérmicos EFG 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Ribofen 25 microgram/hr Transdermal patch (pending) 25 μg/h Transdermal patch Transdermal use 4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Ribofen 50 microgram/hr Transdermal patch (pending) 50 μg/h Transdermal patch Transdermal use 8,25 mg/15 cm2 which release 50 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Ribofen 75 microgram/hr Transdermal patch (pending) 75 μg/h Transdermal patch Transdermal use 12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour United Kingdom ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Ribofen 100 microgram/hr Transdermal patch (pending) 100 μg/h Transdermal patch Transdermal use 16,5 mg/30 cm2 which release 100 μg fentanyl per hour

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Content (Concentration) Germany Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Denmark Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Sweden Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Austria Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Spain Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Finland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use France Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Italy Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Luxembourg Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Norway Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Poland Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use Portugal Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use United Kingdom Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt/Main Xeomin 100 LD50 units Powder for solution for injection For intramuscular use