# C_2006176EN.01001901.xml

| 28.7.2006 | EN | Official Journal of the European Union | C 176/19 |
| --------- | -- | -------------------------------------- | -------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 June 2006 to 30 June 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 176/09)

—   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 |
| -------------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 19.6.2006 | ACOMPLIA | rimonabant | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France | F-75013 Paris | EU/1/06/344/001-009 |
| Sanofi-Aventis | | | | | | | |
| 174, avenue de France | | | | | | | |
| F-75013 Paris | | | | | | | |
| 19.6.2006 | Zimulti | rimonabant | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France | F-75013 Paris | EU/1/06/345/001-009 |
| Sanofi-Aventis | | | | | | | |
| 174, avenue de France | | | | | | | |
| F-75013 Paris | | | | | | | |
| 26.6.2006 | Baraclude | entecavir | 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 | | | | | | | |
| 27.6.2006 | Avaglim | rosiglitazone/glimépiride | SmithKline Beecham plc 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc | 980 Great West Road | Brentford | Middlesex |
| SmithKline Beecham plc | | | | | | | |
| 980 Great West Road | | | | | | | |
| Brentford | | | | | | | |
| Middlesex | | | | | | | |
| TW8 9GS | | | | | | | |
| United Kingdom | | | | | | | |
| 27.6.2006 | RotaTeq | Rotavirus vaccine (live, oral) | Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD | SNC | 8, rue Jonas Salk | F-69007 Lyon |
| Sanofi Pasteur MSD | | | | | | | |
| SNC | | | | | | | |
| 8, rue Jonas Salk | | | | | | | |
| F-69007 Lyon | | | | | | | |
| 27.6.2006 | Tysabri | natalizumab | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland | Athlone | County Westmeath |
| Elan Pharma International Ltd | | | | | | | |
| Monksland | | | | | | | |
| Athlone | | | | | | | |
| County Westmeath | | | | | | | |
| Ireland | | | | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 1.6.2006 | Zometa | 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 | | | | |
| 1.6.2006 | Humira | Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd. | Queenborough |
| Abbott Laboratories Ltd. | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 1.6.2006 | Betaferon | Schering Aktiengesellschaft D-13342 Berlin | Schering Aktiengesellschaft | D-13342 Berlin |
| Schering Aktiengesellschaft | | | | |
| D-13342 Berlin | | | | |
| 2.6.2006 | 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 | | | | |
| 8.6.2006 | Dynepo | 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 | | | | |
| 8.6.2006 | Ventavis | Schering AG Müllerstrasse 170-178 D-13342 Berlin | Schering AG | Müllerstrasse 170-178 |
| Schering AG | | | | |
| Müllerstrasse 170-178 | | | | |
| D-13342 Berlin | | | | |
| 8.6.2006 | Karvea | 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 | | | | |
| 8.6.2006 | Viagra | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 12.6.2006 | Cialis | Lilly ICOS Limited St Bride's House 10 Salisbury Square London EC4Y 8EH United Kingdom | Lilly ICOS Limited | St Bride's House |
| Lilly ICOS Limited | | | | |
| St Bride's House | | | | |
| 10 Salisbury Square | | | | |
| London EC4Y 8EH | | | | |
| United Kingdom | | | | |
| 12.6.2006 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 12.6.2006 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 12.6.2006 | Zerene | Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Research (UK) Limited | Huntercombe Lane South |
| Wyeth Research (UK) Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 12.6.2006 | 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 | | | | |
| 12.6.2006 | 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 | | | | |
| 12.6.2006 | Sonata | 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 | | | | |
| 16.6.2006 | DaTSCAN | GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom | GE Healthcare Limited | Little Chalfont |
| GE Healthcare Limited | | | | |
| Little Chalfont | | | | |
| Bucks HP7 9NA | | | | |
| United Kingdom | | | | |
| 16.6.2006 | Revatio | 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 | | | | |
| 19.6.2006 | DepoCyte | SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kingdom | SkyePharma PLC | 105 Piccadilly |
| SkyePharma PLC | | | | |
| 105 Piccadilly | | | | |
| London W1J 7NJ | | | | |
| United Kingdom | | | | |
| 26.6.2006 | Bondronat | 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 | | | | |
| 26.6.2006 | GONAL-f | Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom | Serono Europe Limited | 56, Marsh Wall |
| Serono Europe Limited | | | | |
| 56, Marsh Wall | | | | |
| London E14 9TP | | | | |
| United Kingdom | | | | |
| 26.6.2006 | Tracleer | 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 | | | | |
| 26.6.2006 | Renagel | Genzyme Europe B.V. Gooimeer 10 Naarden 1411 DD Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| Naarden 1411 DD | | | | |
| Nederland | | | | |
| 26.6.2006 | Carbaglu | Orphan Europe Immeuble ‘Le Guillaumet’ F-92046 Paris La Défense | Orphan Europe | Immeuble ‘Le Guillaumet’ |
| Orphan Europe | | | | |
| Immeuble ‘Le Guillaumet’ | | | | |
| F-92046 Paris La Défense | | | | |
| 26.6.2006 | 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 | | | | |
| 26.6.2006 | Micardis | 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 | | | | |
| 26.6.2006 | MicardisPlus | 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 | | | | |
| 26.6.2006 | 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 | | | | |
| 26.6.2006 | Zenapax | 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 | | | | |
| 27.6.2006 | Kaletra | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |

—   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 |
| --------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 26.6.2006 | Fortovase | 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 | | | | |

—   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 |
| -------------------- | ----------------------------- | ----------------------------------------- | --------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 19.6.2006 | Convenia | cefovecine | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Pfizer Ltd | Ramsgate Road | Sandwich | Kent CT 13 9NJ |
| Pfizer Ltd | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT 13 9NJ | | | | | | | |
| United Kingdom | | | | | | | |

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 30.4.2004, p. 1.

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