EN Official Journal of the European Union C 188/16

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2008 to 30 June 2008

(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) )

(2008/C 188/05)

— 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 17.6.2008 Yasminelle See Annex I See Annex I 19.6.2008 17.6.2008 Belanette See Annex II See Annex II 19.6.2008

(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, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing autorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria Bayer Austria GmbH (Schering Austria GmbH) Herbststr. 6-10 A-1160 Wien Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Belgium Bayer S.A./N.V. Avenue Louise 143 B-1050 Brussel Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Cyprus Bayer Hellas AG 18-20 Sorou Str GR-15125 Amaroussion Athens Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Czech Republic Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Denmark Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Estonia Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Finland Bayer Schering Pharma Oy Pansiontie 47 FI-20210 Turku Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use France Bayer Santé 13, rue Jean Jaurès F-92807 Puteaux Cedex Jasminelle 0,02 mg/3 mg Film-coated tablets Oral use Germany Bayer Vital GmbH D-51368 Leverkusen Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Greece Bayer Hellas AG 18-20 Sorou Str GR-15125 Amaroussion Athens Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Hungary Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Iceland Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Ireland Bayer Ltd The Atrium Blackthorn Road Dublin 18 Ireland Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Italy Bayer S.p.A. Viale Certosa, 130 I-20156 Milano Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Latvia Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Lithuania Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Luxembourg Bayer S.A./N.V. Avenue Louise 143 B-1050 Brussel Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Malta Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Netherlands Bayer B.V. Energieweg 1 3641 RT Mijdrecht Nederland Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Norway Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Poland Schering Polska Sp. z o.o. ul. Migdałowa 4 PL-02-796 Warszawa Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Portugal Berlex, Especialidades Farmacêuticas, Lda. Rua da Quinta do Pinheiro, No. 5 P-2794-003 Carnaxide Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Slovakia Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Slovenia Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Spain Química Farmacéutica Bayer, S.L. Av. Baix Llobregat, 3-5 E-08970 Sant Joan Despí, Barcelona Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use Sweden Bayer Schering Pharma AG D-13342 Berlin Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use United Kingdom Schering Health Care Ltd The Brow Burgess Hill West Sussex RH15 9NE United Kindgom Yasminelle 0,02 mg/3 mg Film-coated tablets Oral use