# C_2007144EN.01000501.xml

| 29.6.2007 | EN | Official Journal of the European Union | C 144/5 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007

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

(2007/C 144/06)

—   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 |
| ---------------------------------------- | ----------------------------- | ------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 2.5.2007 | Focetria | A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1 I-53100 Siena | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1 | I-53100 Siena | EU/1/07/385/001-004 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | | | | |
| Via Fiorentina, 1 | | | | | | | |
| I-53100 Siena | | | | | | | |
| 21.5.2007 | ORENCIA | abatacept | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park | Sanderson Road | Uxbridge UB8 1DH |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park | | | | | | | |
| Sanderson Road | | | | | | | |
| Uxbridge UB8 1DH | | | | | | | |
| United Kingdom | | | | | | | |
| 24.5.2007 | Altargo | retapamulin | Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd. | Greenford Road | Greenford | Middlesex UB6 0NN |
| Glaxo Group Ltd. | | | | | | | |
| Greenford Road | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 0NN | | | | | | | |
| United Kingdom | | | | | | | |

—   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 |
| ------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------- |
| 22.5.2007 | Mycograb | NeuTec Pharma plc Central Manchester & Manchester Children's Hospital NHS Trust Oxford Rd Manchester M13 9WL United Kingdom | NeuTec Pharma plc | Central Manchester & Manchester Children's Hospital NHS Trust |
| NeuTec Pharma plc | | | | |
| Central Manchester & Manchester Children's Hospital NHS Trust | | | | |
| Oxford Rd | | | | |
| Manchester M13 9WL | | | | |
| United Kingdom | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 2.5.2007 | Aranesp | Amgen Europe B.V. Minervum 7061 4817 ZK Breda Nederland | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 2.5.2007 | Liprolog | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 2.5.2007 | BeneFIX | Wyeth Europa Ltd. Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Vfend | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Nespo | Dompé Biotec S.p.A. Via San Martino, 12 I-20122 Milano | Dompé Biotec S.p.A. | Via San Martino, 12 |
| Dompé Biotec S.p.A. | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 2.5.2007 | Invirase | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City AL7 1TW | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Viramune | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 2.5.2007 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation Raheen Industrial Estate Raheen Limerick Ireland | Howmedica International S. de R.L. | Division of Stryker Corporation |
| Howmedica International S. de R.L. | | | | |
| Division of Stryker Corporation | | | | |
| Raheen Industrial Estate | | | | |
| Raheen | | | | |
| Limerick | | | | |
| Ireland | | | | |
| 2.5.2007 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 2.5.2007 | Stocrin | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 3.5.2007 | Protopy | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| 3.5.2007 | Crixivan | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| United Kingdom | | | | |
| 3.5.2007 | Protopic | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| 3.5.2007 | Infanrix Hexa | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 3.5.2007 | Infanrix Penta | GlaxoSmithKline Biologicals s.a. rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals s.a. | rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| rue de l'Institut 89 | | | | |
| B-1330 Rixensart | | | | |
| 3.5.2007 | Humalog | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 11.5.2007 | Prialt | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 14.5.2007 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 14.5.2007 | Hepsera | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park Abington |
| Gilead Sciences International Limited | | | | |
| Granta Park Abington | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 14.5.2007 | Humira | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 14.5.2007 | Trudexa | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 15.5.2007 | Omnitrope | Sandoz GmbH Biochemiestraße 10 A-Kundl 6250 | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-Kundl 6250 | | | | |
| 15.5.2007 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 15.5.2007 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 15.5.2007 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park | | | | |
| Chineham | | | | |
| Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| United Kingdom | | | | |
| 22.5.2007 | Thelin | Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ United Kingdom | Encysive (UK) Limited | Alder Castle House |
| Encysive (UK) Limited | | | | |
| Alder Castle House | | | | |
| 10 Noble Street | | | | |
| London EC2V 7QJ | | | | |
| United Kingdom | | | | |
| 22.5.2007 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High Road London W4 4AL United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High Road | | | | |
| London W4 4AL | | | | |
| United Kingdom | | | | |
| 22.5.2007 | Teslascan | GE Healthcare AS Nycoveien 1-2 P.O. Box 4220 Nydalen N-0401 Oslo | GE Healthcare AS | Nycoveien 1-2 |
| GE Healthcare AS | | | | |
| Nycoveien 1-2 | | | | |
| P.O. Box 4220 Nydalen | | | | |
| N-0401 Oslo | | | | |
| 22.5.2007 | Opatanol | Alcon Laboratories (UK) Ltd. Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 30.5.2007 | Xolair | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road | | | | |
| Horsham | | | | |
| West Sussex RH12 5AB | | | | |
| United Kingdom | | | | |
| 30.5.2007 | Caelyx | Schering Plough Europe rue de Stalle, 73 B-1180 Bruxelles Stallestraat, 73 B-1180 Brussel | Schering Plough Europe | rue de Stalle, 73 |
| Schering Plough Europe | | | | |
| rue de Stalle, 73 | | | | |
| B-1180 Bruxelles | | | | |
| Stallestraat, 73 | | | | |
| B-1180 Brussel | | | | |
| 30.5.2007 | Ventavis | Bayer Schering Pharma AG Müllerstraße 170-178 D-13342 Berlin | Bayer Schering Pharma AG | Müllerstraße 170-178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstraße 170-178 | | | | |
| D-13342 Berlin | | | | |
| 30.5.2007 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden Nederland | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |
| 30.5.2007 | LeukoScan | Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt | Immunomedics GmbH | Otto-Röhm-Straße 69 |
| Immunomedics GmbH | | | | |
| Otto-Röhm-Straße 69 | | | | |
| D-64293 Darmstadt | | | | |
| 30.5.2007 | Ziagen | Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd. | Greenford Road |
| Glaxo Group Ltd. | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 30.5.2007 | Kivexa | Glaxo Group Ltd. Greenford Road Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd. | Greenford Road |
| Glaxo Group Ltd. | | | | |
| Greenford Road | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 30.5.2007 | AVANDIA | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 30.5.2007 | Viramune | Boehringer Ingelheim International GmbH Binger Straße 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 30.5.2007 | Avaglim | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road |
| SmithKline Beecham plc | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 31.5.2007 | Ketek | Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 31.5.2007 | Levviax | Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |

—   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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 14.5.2007 | Nobilis Influenza H7N1 | Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test. | Intervet International B.V. | EU/2/07/073/001-004 | Emulsion for injection | QI01AA23 | 16.5.2007 |

—   Modification 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 | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------- | ----------------------------- | -------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 15.5.2007 | METACAM | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein | | | | |

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 |

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

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