# C_2006321EN.01001301.xml

| 29.12.2006 | EN | Official Journal of the European Union | C 321/13 |
| ---------- | -- | -------------------------------------- | -------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2006 to 30 November 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 321/06)

—   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 |
| -------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- | ----------------------------------------------- | -------------------- |
| 20.11.2006 | BYETTA | exenatide | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5 | 3991 RA Houten | Nederland |
| Eli Lilly Nederland B.V. | | | | | | | |
| Grootslag 1-5 | | | | | | | |
| 3991 RA Houten | | | | | | | |
| Nederland | | | | | | | |
| 20.11.2006 | Sprycel | dasatinib | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park | Sanderson Road | Uxbridge UD8 1DH |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park | | | | | | | |
| Sanderson Road | | | | | | | |
| Uxbridge UD8 1DH | | | | | | | |
| 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 |
| --------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- |
| 7.11.2006 | Exubera | PFIZER Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | PFIZER Ltd | Ramsgate Road |
| PFIZER Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich Kent CT 13 9NJ | | | | |
| United Kingdom | | | | |
| 7.11.2006 | Humira | Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd. | Queenborough |
| Abbott Laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 7.11.2006 | Trudexa | Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd. | Queenborough Kent ME11 5EL |
| Abbott Laboratories Ltd. | | | | |
| Queenborough Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 14.11.2006 | 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 | | | | |
| 14.11.2006 | Zevalin | Schering AG Müllerstrasse 170-178 D-13342 Berlin | Schering AG | Müllerstrasse 170-178 |
| Schering AG | | | | |
| Müllerstrasse 170-178 | | | | |
| D-13342 Berlin | | | | |
| 20.11.2006 | 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 | | | | |
| 20.11.2006 | Hycamtin | 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 | | | | |
| 20.11.2006 | Yttriga | QSA Global GmbH Gieselweg 1 D-38110 Braunschweig | QSA Global GmbH | Gieselweg 1 |
| QSA Global GmbH | | | | |
| Gieselweg 1 | | | | |
| D-38110 Braunschweig | | | | |
| 20.11.2006 | Liprolog | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 20.11.2006 | 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 | | | | |
| 20.11.2006 | 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 | | | | |
| 20.11.2006 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United-Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United-Kingdom | | | | |
| 22.11.2006 | TRIZIVIR | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 22.11.2006 | Evista | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 22.11.2006 | Optruma | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 22.11.2006 | PEGASYS | 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 | | | | |
| 22.11.2006 | Tarceva | 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 | | | | |
| 22.11.2006 | 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 | | | | |
| 22.11.2006 | Hycamtin | 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 | | | | |
| 22.11.2006 | Avandamet | 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 | | | | |
| 22.11.2006 | 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 | | | | |
| 24.11.2006 | Ariclaim | 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 | | | | |
| 24.11.2006 | 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 | | | | |
| 24.11.2006 | 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 | | | | |
| 24.11.2006 | Pedea | Orphan Europe SARL Immeuble ‘Le Guillaumet’ F-92046 Paris-La-Défense | Orphan Europe SARL | Immeuble ‘Le Guillaumet’ |
| Orphan Europe SARL | | | | |
| Immeuble ‘Le Guillaumet’ | | | | |
| F-92046 Paris-La-Défense | | | | |
| 24.11.2006 | Aptivus | 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 | | | | |
| 24.11.2006 | Replagal | Shire Human Genetic Therapies AB Rinkebyvägen 11B S-182 36 Danderyd | Shire Human Genetic Therapies AB | Rinkebyvägen 11B |
| Shire Human Genetic Therapies AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 24.11.2006 | Levitra | Bayer AG D-51368 Leverkusen, | Bayer AG | D-51368 Leverkusen, |
| Bayer AG | | | | |
| D-51368 Leverkusen, | | | | |
| 24.11.2006 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 24.11.2006 | Xeristar | 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 | | | | |
| 24.11.2006 | Cymbalta | Eli Lilly Nederland BV Grootslag 1-5 3991 RA Houten Nederland | Eli Lilly Nederland BV | Grootslag 1-5 |
| Eli Lilly Nederland BV | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| Nederland | | | | |
| 28.11.2006 | Ziagen | Glaxo Group Ltd, Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd, Greenford | Middlesex UB6 0NN |
| Glaxo Group Ltd, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.11.2006 | Glivec | 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 | | | | |
| 28.11.2006 | Tysabri | Elan Pharma International Ltd. Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd. | Monksland |
| Elan Pharma International Ltd. | | | | |
| Monksland | | | | |
| Athlone | | | | |
| County Westmeath | | | | |
| Ireland | | | | |
| 28.11.2006 | Ebixa | H. Lundbeck A/S, Ottiliavej 9 DK-2500 Valby | H. Lundbeck A/S, Ottiliavej 9 | DK-2500 Valby |
| H. Lundbeck A/S, Ottiliavej 9 | | | | |
| DK-2500 Valby | | | | |
| 28.11.2006 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 D-60318 Frankfurt/Main | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| D-60318 Frankfurt/Main | | | | |
| 28.11.2006 | Kepivance | 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 | | | | |
| 28.11.2006 | 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 | | | | |
| 28.11.2006 | Kivexa | Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Berkeley Avenue |
| Glaxo Group Ltd | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.11.2006 | YENTREVE | 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 | | | | |
| 28.11.2006 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| United Kingdom | | | | |
| 29.11.2006 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead, Berkshire, SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane South |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead, | | | | |
| Berkshire, SL6 0PH | | | | |
| United Kingdom | | | | |
| 29.11.2006 | Aldara | Laboratoires 3M Santé Boulevard de l'Oise F-95029 Cergy Pontoise Cedex | Laboratoires 3M Santé | Boulevard de l'Oise |
| Laboratoires 3M Santé | | | | |
| Boulevard de l'Oise | | | | |
| F-95029 Cergy Pontoise Cedex | | | | |
| 29.11.2006 | Foscan | Biolitec pharma Ltd United Drug House Magna Drive Dublin 24 Ireland | Biolitec pharma Ltd | United Drug House |
| Biolitec pharma Ltd | | | | |
| United Drug House | | | | |
| Magna Drive | | | | |
| Dublin 24 | | | | |
| Ireland | | | | |
| 29.11.2006 | Emselex | 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 | | | | |
| 29.11.2006 | 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 | | | | |

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

| 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 |
| -------------------- | ----------------------------- | ------------------------------------------- | --------------------------------------------- | -------------------- |
| 14.11.2006 | Monotard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 14.11.2006 | Ultratard | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |

—   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 |
| ------------------------------ | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 14.11.2006 | Yarvitan | Mitratapide | Janssen Animal Health B.V.B.A. Turnhoutseweg, 30 B-2340 Beerse | Janssen Animal Health B.V.B.A. | Turnhoutseweg, 30 | B-2340 Beerse | EU/2/06/063/001-003 |
| Janssen Animal Health B.V.B.A. | | | | | | | |
| Turnhoutseweg, 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |

—   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 |
| ------------------------- | ----------------------------- | ---------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 20.11.2006 | Virbagen Omega | VIRBAC S.A. 1ere Avenue 2065 m L.I.D. F-06516 Carros | VIRBAC S.A. | 1ere Avenue 2065 m L.I.D. |
| VIRBAC S.A. | | | | |
| 1ere Avenue 2065 m L.I.D. | | | | |
| F-06516 Carros | | | | |

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, 30.4.2004, p. 1.

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