EN Official Journal of the European Union C 215/11

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004

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

(2004/C 215/06)

— 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 29.7.2004 Lopid (art 30) See Annex I See Annex I 30.7.2004 11.8.2004 Eprinomectin (Art 34) See Annex II See Annex II 12.8.2004

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Pfizer Corporation Austria Ges.m.b.H Seidengasse 33–35 A – 1070 Wien Gevillon 450 mg Film coated tablets Oral use Austria Pfizer Corporation Austria Ges.m.b.H Seidengasse 33–35 A – 1070 Wien Gevillon 900 mg Film coated tablets Oral use Belgium Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 300 mg Capsules Oral use Belgium Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 600 mg Film-coated tablets Oral use Belgium Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 900 mg Film-coated tablets Oral use Denmark Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 300 mg Capsules Oral use Denmark Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 450 mg Film-coated tablets Oral use Denmark Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 600 mg Film-coated tablets Oral use Finland Pfizer Oy P.O. Box 45 FIN–02601 Espoo Lopid 300 mg Capsules Oral use Finland Pfizer Oy P.O. Box 45 FIN–02601 Espoo Lopid 600 mg Film-coated tablets Oral use France Pfizer 23-25 Avenue Du Dr. Lannelongue F–75014 Paris Lipur 450 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D–76139 Karlsruhe Gevilon 450 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D–76139 Karlsruhe Gevilon 600 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D–76139 Karlsruhe Gevilon uno 900 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D–76139 Karlsruhe Continulipid 450 mg Film-coated tablets Oral use Germany Parke-Davis GmbH Pfizerstrasse 1 D–76139 Karlsruhe Continulipid 600 mg Film-coated tablets Oral use Greece Pfizer Hellas A.E. Alketou Street 5 Athens Lopid 600 mg Film-coated tablets Oral use Greece Pfizer Hellas A.E. Alketou Street 5 Athens Lopid 900 mg Film-coated tablets Oral use Iceland Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 300 mg Capsules Oral use Iceland Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 450 mg Film-coated tablets Oral use Iceland Pfizer ApS Lautrupvang 8 DK–2750 Ballerup Lopid 600 mg Film-coated tablets Oral use Ireland Warner Lambert UK Ltd trading as: Parke Davis Lambert Court Chestnut Avenue Eastleigh Hampshire SO53 3ZQ United Kingdom Lopid 300 mg Capsules Oral use Ireland Warner Lambert UK Ltd trading as: Parke Davis Lambert Court Chestnut Avenue Eastleigh Hampshire SO53 3ZQ United Kingdom Lopid 600 mg Film coated tablets Oral use Italy Pfizer Italia S.r.l. Via Valbondione 113 I–00188 Roma Lopid 600 mg Tablets Oral use Italy Pfizer Italia S.r.l. Via Valbondione 113 I–00188 Roma Lopid 900 mg Tablets Oral use Italy Pfizer Italia S.r.l. Via Valbondione 113 I–00188 Roma Lopid TC 900 mg Granules Oral use Italy Pfizer Italia S.r.l. Via Valbondione 113 I–00188 Roma Lopid TC 1200 mg Granules Oral use Luxembourg Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 300 mg Capsules Oral use Luxembourg Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 600 mg Film-coated tablets Oral use Luxembourg Pfizer S.A. Rue Léon Theodor 102 B–1090 Bruxelles Lopid 900 mg Film-coated tablets Oral use Netherlands Pfizer BV Postbus 37 NL–2900 AA Capelle a/d Ijssel Lopid 600 mg Coated tablets Oral use Netherlands Pfizer BV Postbus 37 NL–2900 AA Capelle a/d Ijssel Lopid 900 mg Coated tablets Oral use Portugal Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 2740-244 Porto Salvo Lopid 300 mg Capsules Oral use Portugal Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 2740-244 Porto Salvo Lopid 600 mg Coated tablets Oral use Portugal Laboratórios Pfizer, Lda., Lagoas Park - Edifício no 10 2740-244 Porto Salvo Lopid 900 mg Coated tablets Oral use Spain Parke-Davis, S.L. (Pfizer Group) Av. de Europa 20-B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Lopid 600 mg Tablets Oral use Spain Parke-Davis, S.L. (Pfizer Group) Av. de Europa 20-B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Lopid 900 mg Tablets Oral use Sweden Pfizer AB Nytorpsvägen 36 Box 501 S–183 25 Täby Lopid 300 mg Capsules Oral use Sweden Pfizer AB Nytorpsvägen 36 Box 501 S–183 25 Täby Lopid 450 mg Film coated tablets Oral use Sweden Pfizer AB Nytorpsvägen 36 Box 501 S–183 25 Täby Lopid 600 mg Film coated tablets Oral use United Kingdom Warner Lambert UK Ltd trading as: Parke Davis Lambert Court Chestnut Avenue Eastleigh,Hampshire SO53 3ZQ United Kingdom Lopid 300 mg Capsules Oral use United Kingdom Warner Lambert UK Ltd trading as: Parke Davis Lambert Court Chestnut Avenue Eastleigh,Hampshire SO53 3ZQ United Kingdom Lopid 600 mg Film coated tablets Oral use