EN Official Journal of the European Union C 174/10

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2007 to 30 June 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 174/05)

— 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 7.6.2007 Tracleer Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom This Decision is addressed to the Member States 8.6.2007 14.6.2007 Revlimid Celgene Europe Limited 8 The Square Stockley Park Uxbridge Middlesex UB11 1FW United Kingdom This Decision is addressed to the Member States 18.6.2007 14.6.2007 Mifegyne See Annex I See Annex I 18.6.2007 20.6.2007 Soliris Alexion Europe SAS 54-56, Avenue Hoche F-75008 Paris This Decision is addressed to the Member States 21.6.2007 29.6.2007 Bovilis BVD See Annex II See Annex II 2.7.2007 29.6.2007 Siklos Addmedica 84, rue d'Amsterdam F-75009 Paris This Decision is addressed to the Member States 3.7.2007

— 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 13.6.2007 Suramox 15 % LA et Stabox 15 % LA See Annex III See Annex III 14.6.2007

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Invented name Strength Pharmaceutical form Route of administration Austria Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Belgium Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Denmark Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Estonia Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Finland Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use France Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Germany Contragest GmbH Pharmavertrieb Kelsterbacher Str. 28 D-64546 Walldorf-Mörfelden Mifegyne 200 mg Tablet Oral use Greece Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Latvia Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Luxembourg Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Norway Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Spain Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use Sweden Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use The Netherlands Bipharma B.V. Postbus 151 1380 AD Weesp Nederland Mifegyne 200 mg Tablet Oral use UK Exelgyn 216, Boulevard St Germain F-75 007 Paris Mifegyne 200 mg Tablet Oral use

ANNEX II NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER Member State Applicant or Marketing Authorisation Holder Product invented name Pharmaceutical form Strength Animal species Frequency and route of administration Recommended dose Austria Intervet Deutschland GmbH Feldstrasse 1a D-85716 Unterschleissheim Tel. (49-89) 310 062 59 Fax (49-89) 310 03 27 Bovilis BVD-MD Suspension for injection Per 2 ml dose: 50 ELISA units, inducing ≥ 4,6 log2 VN units Cattle Intramuscular injection (Immunisation schedules are given in the product information.) One dose = 2 ml Belgium Intervet Belgium Bedrijvenlaan 7 B-2800 Mechelen Tel. (32-15) 43 67 28 Fax (32-15) 43 67 33 Bovilis BVD As above As above As above As above As above Bulgaria Intervet Bulgaria EOOD 7, Iskarsko shose blvd BG-1528 Sofia Tel. (359-2) 970 10 70 Fax (359-2) 971 09 00 Bovilis BVD As above As above As above As above As above Cyprus Medivet Suppliers Ltd 87c Aglandjias Avenue PO Box 20932 CY-1665 Nicosia Tel. (357) 22 33 66 05 Fax (357) 22 33 66 07 Bovilis BVD As above As above As above As above As above Czech Republic Intervet s.r.o. Zlicin Business Centre Na Radosti 413 CZ-155 21 Prague 5 Tel. (420-2) 33 34 40 25 Fax (420-2) 33 34 40 22 Bovilis BVD As above As above As above As above As above Denmark Intervet Danmark AS PO Box 66 Literbuen 9 DK-2740 Skovlunde Tel. (45-44) 54 69 00 Fax (45-44) 53 19 55 Bovilis BVD As above As above As above As above As above Estonia Intervet Baltic States Vasario 16-osios 9-6A LT-Kaunas 3000 Tel. (370) 37 32 16 60 Fax (370) 37 20 12 93 Bovilis BVD As above As above As above As above As above France Intervet S.A. Rue Olivier de Serres Angers Technopole BP 17144 F-49071 Beaucouzé Cedex Tel. (33-2) 41 22 83 83 Fax (33-2) 41 22 83 00 Bovilis BVD As above As above As above As above As above Germany Intervet Deutschland GmbH Feldstrasse 1a D-85716 Unterschleissheim Tel. (49-89) 310 062 59 Fax (49-89) 310 03 27 Bovilis BVD-MD As above As above As above As above As above Greece Intervet Hellas S.A. 3, Paparigopoulou Street GR-152 32 Halandri Athens Tel. (30-210) 689 04 11 Fax (30-210) 683 25 23 Bovilis BVD As above As above As above As above As above Hungary Intervet Hungaria Kft. Boráros tér. 7/2. 7.e.13 H-1095 Budapest Tel. (36-1) 456 30 90 Fax (36-1) 456 30 99 Bovilis BVD As above As above As above As above As above Ireland Intervet Ireland Ltd Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland Tel. (353-1) 463 73 30 Fax (353-1) 451 19 06 Bovilis BVD As above As above As above As above As above Italy Intervet Italia S.r.l. Via W. Tobagi 7 I-20068 Peschiera Borromeo — Milano Tel. (39) 02 51 68 61 Fax (39) 02 51 68 66 87 Bovilis BVD As above As above As above As above As above Latvia Intervet Baltic States Vasario 16-osios 9-6A LT-Kaunas 3000 Tel. (370) 37 32 16 60 Fax (370) 37 20 12 93 Bovilis BVD As above As above As above As above As above Lithuania Intervet Baltic States Vasario 16-osios 9-6A LT-Kaunas 3000 Tel. (370) 37 32 16 60 Fax (370) 37 20 12 93 Bovilis BVD As above As above As above As above As above Luxembourg Intervet Belgium Bedrijvenlaan 7 B-2800 Mechelen Tel. (32-15) 43 67 28 Fax (32-15) 43 67 33 Bovilis BVD As above As above As above As above As above The Netherlands Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland Tel. (31-485) 58 76 52 Fax (31-485) 58 76 53 Bovilis BVD As above As above As above As above As above Poland Intervet International BV Sp. z o.o. Przedstawicielstwo w Polsce ul. Wybrzeże Gdyńskie 6c PL-01-531 Warszawa Tel. (48-22) 620 11 47 Fax (48-22) 620 29 35 Bovilis BVD As above As above As above As above As above Portugal Intervet Portuguesa Ltd Estrada Nacional 249, Km 14,2 P-2725-397 Mem Martins Codes Tel. (351-21) 922 83 00 Fax (351-21) 920 22 31 Bovilis BVD As above As above As above As above As above Slovakia Representative of Intervet in the Slovak Rep. Palárikova 16 SK-040 01 Košice Tel. (421-55) 676 94 05 Fax (421-55) 676 98 73 Bovilis BVD As above As above As above As above As above Slovenia Intervet International Podružnica Križna 10 SLO-1000 Ljubljana Tel. (386-1) 541 75 67 Fax (386-1) 523 35 67 Bovilis BVD As above As above As above As above As above Spain Laboratorios Intervet, S.A. Polígono Industrial «El Montalva» Apartado 3006 E-37080 Salamanca Tel. (34-923) 19 03 45 Fax: (34-923) 19 03 47 Bovilis BVD As above As above As above As above As above UK Intervet UK Ltd Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ United Kingdom Tel. (44-1908) 66 50 50 Fax (44-1908) 66 47 78 Bovilis BVD As above As above As above As above As above