EN Official Journal of the European Union C 124/11

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006

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

(2006/C 124/04)

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 3.4.2006 Nifedipine See Annex I See Annex I 4.4.2006 3.4.2006 Adartrel See Annex II See Annex II 4.4.2006 10.4.2006 Prograf See Annex III See Annex III 12.4.2006

(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, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Applicant Name Strength Pharmaceutical Form Route of administration Belgium International Pharmaceutical Services (IPS) Jozef Nellenslei 10 B-2100 Deurne Nifedipine TEVA 30/60 mg retard 30 mg/60 mg prolonged-release tablets Oral use Netherlands Pharmamatch BV Stationsweg Oost 281-D 3931 ER Woudenberg The Netherlands Nifedipine Pharmamatch retard 30/60 mg 30 mg/60 mg prolonged-release tablets Oral use United Kingdom Neolab Ltd. 57 High Street Odiham Hants RG29 1LF United Kingdom Neozipine XL 30/60 mg 30 mg/60 mg prolonged-release tablets Oral use

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES MMember state Marketing authorization Holder Applicant Invented name Strengths Pharmaceutical form Route of administration Austria Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Austria Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Austria Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Austria Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Belgium Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Belgium Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Belgium Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Belgium Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Cyprus Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Cyprus Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Cyprus Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Cyprus Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Czech Republic GlaxoSmithKline s.r.o. Na Pankráci 17/1685 CZ-140 21 Praha 4 ADARTREL 0,25 mg Film-coated tablet Oral use Czech Republic GlaxoSmithKline s.r.o. Na Pankráci 17/1685 CZ-140 21 Praha 4 ADARTREL 0,5 mg Film-coated tablet Oral use Czech Republic GlaxoSmithKline s.r.o. Na Pankráci 17/1685 CZ-140 21 Praha 4 ADARTREL 1,0 mg Film-coated tablet Oral use Czech Republic GlaxoSmithKline s.r.o. Na Pankráci 17/1685 CZ-140 21 Praha 4 ADARTREL 2,0 mg Film-coated tablet Oral use Denmark Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Denmark Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Denmark Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Denmark Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Estonia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Estonia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Estonia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Estonia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Finland GlaxoSmithKline Oy Piispansilta 9 A FIN-02230 Espoo ADARTREL 0,25 mg Film-coated tablet Oral use Finland GlaxoSmithKline Oy Piispansilta 9 A FIN-02230 Espoo ADARTREL 0,5 mg Film-coated tablet Oral use Finland GlaxoSmithKline Oy Piispansilta 9 A FIN-02230 Espoo ADARTREL 1,0 mg Film-coated tablet Oral use Finland GlaxoSmithKline Oy Piispansilta 9 A FIN-02230 Espoo ADARTREL 2,0 mg Film-coated tablet Oral use France Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use France Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use France Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use France Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München ADARTREL 0,25 mg Film-coated tablet Oral use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München ADARTREL 0,5 mg Film-coated tablet Oral use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München ADARTREL 1,0 mg Film-coated tablet Oral use Germany GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11 D-80339 München ADARTREL 2,0 mg Film-coated tablet Oral use Greece GlaxoSmithKline α.ε.β.ε Κηφισίας 266, 152 32 Χαλάνδρι Αθήνα Ελλάδα ADARTREL 0,25 mg Film-coated tablet Oral use Greece GlaxoSmithKline α.ε.β.ε Κηφισίας 266, 152 32 Χαλάνδρι Αθήνα Ελλάδα ADARTREL 0,5 mg Film-coated tablet Oral use Greece GlaxoSmithKline α.ε.β.ε Κηφισίας 266, 152 32 Χαλάνδρι Αθήνα Ελλάδα ADARTREL 1,0 mg Film-coated tablet Oral use Greece GlaxoSmithKline α.ε.β.ε Κηφισίας 266, 152 32 Χαλάνδρι Αθήνα Ελλάδα ADARTREL 2,0 mg Film-coated tablet Oral use Hungary Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Hungary Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Hungary Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Hungary Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Iceland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Iceland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Iceland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Iceland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Ireland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Ireland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Ireland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Ireland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Italy Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Italy Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Italy Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Italy Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Latvia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Latvia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Latvia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Latvia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Lithuania Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Lithuania Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Lithuania Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Lithuania Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Luxembourg Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Luxembourg Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Luxembourg Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Luxembourg Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Malta Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Malta Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Malta Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Malta Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Netherlands Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Netherlands Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Netherlands Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Netherlands Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Norway Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Norway Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Norway Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Norway Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Poland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Poland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Poland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Poland Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Portugal Beecham Portuguesa Produtos Farmacêuticos e Químicos, Lda. Rua Dr. António Loureiro Borges, n.o 3 Arquiparque — Miraflores P-1495-131 Algés ADARTREL 0,25 mg Film-coated tablet Oral use Portugal Beecham Portuguesa Produtos Farmacêuticos e Químicos, Lda. Rua Dr. António Loureiro Borges, n.o 3 Arquiparque — Miraflores P-1495-131 Algés ADARTREL 0,5 mg Film-coated tablet Oral use Portugal Beecham Portuguesa Produtos Farmacêuticos e Químicos, Lda. Rua Dr. António Loureiro Borges, n.o 3 Arquiparque — Miraflores P-1495-131 Algés ADARTREL 1,0 mg Film-coated tablet Oral use Portugal Beecham Portuguesa Produtos Farmacêuticos e Químicos, Lda. Rua Dr. António Loureiro Borges, n.o 3 Arquiparque — Miraflores P-1495-131 Algés ADARTREL 2,0 mg Film-coated tablet Oral use Slovakia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Slovakia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Slovakia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Slovakia Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Slovenia GSK d.o.o., Ljubljana Knezov stradon 90 SLO-1000 Ljubljana ADARTREL 0,25 mg Film-coated tablet Oral use Slovenia GSK d.o.o., Ljubljana Knezov stradon 90 SLO-1000 Ljubljana ADARTREL 0,5 mg Film-coated tablet Oral use Slovenia GSK d.o.o., Ljubljana Knezov stradon 90 SLO-1000 Ljubljana ADARTREL 1,0 mg Film-coated tablet Oral use Slovenia GSK d.o.o., Ljubljana Knezov stradon 90 SLO-1000 Ljubljana ADARTREL 2,0 mg Film-coated tablet Oral use Spain Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Spain Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Spain Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Spain Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use Sweden Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use Sweden Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use Sweden Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use Sweden Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use UK Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,25 mg Film-coated tablet Oral use UK Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 0,5 mg Film-coated tablet Oral use UK Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 1,0 mg Film-coated tablet Oral use UK Laboratoire GlaxoSmithKline 100 Route de Versailles F-78163 Marly-le-Roi Cedex ADARTREL 2,0 mg Film-coated tablet Oral use