EN Official Journal of the European Union C 259/6

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

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )

(2006/C 259/04)

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 20.9.2006 Gardasil Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/06/357/001-017 Suspension for injection J07BM1 22.9.2006 20.9.2006 Silgard Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed) Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/06/358/001-017 Suspension for injection J07BM1 22.9.2006 20.9.2006 Luminity Perflutren Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe 185 B-1170 Brussels EU/1/06/361/001 Solution for dispersion for injection or infusion V08D A04 22.9.2006 26.9.2006 Suboxone buprenorphine/ naloxone Schering Plough Europ Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-180 Brussel EU/1/06/359/001-004 Sublingual tablet N07B C51 28.9.2006 26.9.2006 Champix varenicline tartrate Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/06/360/001-010 Film-coated tablet N07BA03 28.9.2006

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 5.9.2006 Alpheon BioPartners GmbH Eisenstrasse 3 D-65428 Rüsselsheim Non applicable 7.9.2006

— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product Holder of the marketing authorization Number of the entry in the Community Register Date of notification 1.9.2006 Aldara Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex EU/1/98/080/001 5.9.2006 1.9.2006 Angiox The Medicines Company UK Ltd Suite B Park House, 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom EU/1/04/289/001-002 7.9.2006 1.9.2006 Rebif Serono Europe Ltd. 56, Marsh Wall London E14 9TP United Kingdom EU/1/98/063/001-007 7.9.2006 1.9.2006 Iscover Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b 11.9.2006 1.9.2006 Fasturtec Sanofi-Aventis 174, avenue de France F-75013 Paris EU/1/00/170/001-002 7.9.2006 1.9.2006 Neoclarityn Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/00/161/001-034 7.9.2006 1.9.2006 Replagal TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd EU/1/01/189/001-006 7.9.2006 1.9.2006 Liprolog Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/01/195/003 EU/1/01/195/006 EU/1/01/195/011 EU/1/01/195/014 7.9.2006 1.9.2006 Fabrazyme Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland EU/1/01/188/001-006 7.9.2006 1.9.2006 Azomyr Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/00/157/001-034 7.9.2006 1.9.2006 Aerius Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/00/160/001-035 6.9.2006 1.9.2006 Remicade Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland EU/1/99/116/001-003 6.9.2006 1.9.2006 Plavix Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b 6.9.2006 1.9.2006 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main EU/1/00/134/030-037 6.9.2006 1.9.2006 Viramune Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein EU/1/97/055/001-003 6.9.2006 1.9.2006 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom EU/1/99/110/001-009 6.9.2006 1.9.2006 Betaferon Schering Aktiengesellschaft D-13342 Berlin EU/1/95/003/003-006 6.9.2006 1.9.2006 Viread Gilead Sciences International Limited Cambridge CB1 6GT United Kingdom EU/1/01/200/001 7.9.2006 1.9.2006 Stocrin Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/99/111/001-009 6.9.2006 1.9.2006 Rebetol Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/99/107/001-005 7.9.2006 1.9.2006 Humalog Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland EU/1/96/007/005 EU/1/96/007/008 EU/1/96/007/016 EU/1/96/007/024 EU/1/96/007/027 7.9.2006 1.9.2006 Apidra Sanofi-Aventis Deutschland GmbH Brueningstrasse 50 D-65926 Frankfurt am Main EU/1/04/285/001-036 7.9.2006 1.9.2006 ViraferonPeg Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/00/132/001-050 7.9.2006 1.9.2006 IntronA Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/99/127/001-044 8.9.2006 1.9.2006 Viraferon Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/99/128/001-037 8.9.2006 1.9.2006 PegIntron Schering Plough Europe Rue de Stalle, 73 B-1180 Bruxelles/ Stallestraat, 73 B-1180 Brussel EU/1/00/131/001-050 8.9.2006 1.9.2006 Invanz Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/02/216/001-002 8.9.2006 7.9.2006 Abilify Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom EU/1/04/276/001-035 12.9.2006 7.9.2006 Lyrica Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/1/04/279/001-035 12.9.2006 7.9.2006 Rapamune Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/01/171/001 EU/1/01/171/007-012 12.9.2006 7.9.2006 Avonex Biogen Idec Ltd 5 Roxborough Way Foundation Park, Maidenhead Berkshire SL6 3UD United Kindgom EU/1/97/033/001-003 12.9.2006 7.9.2006 Levviax Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/192/001-005 12.9.2006 7.9.2006 Ketek Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 Antony EU/1/01/191/001-005 12.9.2006 7.9.2006 Zonegran Eisai Limited 3, Shortlands London W6 8EE United Kingdom EU/1/04/307/001-010 12.9.2006 12.9.2006 Arixtra Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/02/206/018-020 15.9.2006 12.9.2006 ProQuad Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon EU/1/05/323/001-013 14.9.2006 12.9.2006 Tamiflu Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/02/222/001-002 14.9.2006 12.9.2006 Quixidar Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom EU/1/02/207/018-020 15.9.2006 12.9.2006 Zyprexa Velotab Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-008 14.9.2006 12.9.2006 Zyprexa Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-022 14.9.2006 13.9.2006 Zyprexa Velotab Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/99/125/001-008 15.9.2006 13.9.2006 Zyprexa Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-022 15.9.2006 14.9.2006 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 18.9.2006 14.9.2006 Prialt Elan Pharma International Ltd WIL House Shannon Business Park Shannon County Clare Ireland EU/1/04/302/001-004 18.9.2006 Eisai Limited 3, Shortlands London W6 8EE United Kingdom 18.9.2006 18.9.2006 DaTSCAN GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom EU/1/00/135/001-002 20.9.2006 21.9.2006 Fuzeon Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom EU/1/03/252/001-003 25.9.2006 21.9.2006 Glivec Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/01/198/001-013 25.9.2006 26.9.2006 Aclasta Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom EU/1/05/308/001-002 28.9.2006 26.9.2006 Enbrel Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom EU/1/99/126/013-018 28.9.2006 29.9.2006 Cancidas Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom EU/1/01/196/001-003 3.10.2006

— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Date of the decision Name of the medicinal product INN (International Non-Proprietary Name) Holder of the marketing authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 1.9.2006 Poulvac FluFend H5N3 RG Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) 256 — 4046 HA Units Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom EU/2/06/060/001-002 Emulsion for injection QI01AA23 7.9.2006 1.9.2006 Nobilis Influenza H5N2 Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test. Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland EU/2/06/061/001-004 Emulsion for injection QI01AA23 7.9.2006 29.9.2006 Cerenia Maropitant Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom EU/2/06/062/001-004 Tablet QA04AD90 3.10.2006 EU/2/06/062/005 Solution for injection

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency 7, Westferry Circus, Canary Wharf LONDON E14 4HB United Kingdom

(1) OJ L 136 of 30 April 2004, page 1.