# C_2004172EN.01000401.xml

| 2.7.2004 | EN | Official Journal of the European Union | C 172/4 |
| -------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorization in respect of medicinal products from 15/04/2004 to 15/05/2004

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93( 1 ))

(2004/C 172/03)

Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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 |
| ----------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 26.04.2004 | Velcade | Millenium Pharmaceuticals Ltd Building 3 Chiswick Park 566 Chiswick High Road Chiswick London W4 5YA United Kingdom | Millenium Pharmaceuticals Ltd | Building 3 Chiswick Park |
| Millenium Pharmaceuticals Ltd | | | | |
| Building 3 Chiswick Park | | | | |
| 566 Chiswick High Road | | | | |
| Chiswick | | | | |
| London W4 5YA | | | | |
| United Kingdom | | | | |
| 28.04.2004 | Lysodren | Laboratoire HRA Pharma 19, rue Frédérick Lemaitre F-75020 Paris | Laboratoire HRA Pharma | 19, rue Frédérick Lemaitre |
| Laboratoire HRA Pharma | | | | |
| 19, rue Frédérick Lemaitre | | | | |
| F-75020 Paris | | | | |
| 28.04.2004 | Dukoral | SBL Vaccin AB S-105 21 Stockholm | SBL Vaccin AB | S-105 21 Stockholm |
| SBL Vaccin AB | | | | |
| S-105 21 Stockholm | | | | |

Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93) 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 |
| -------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 22.04.2004 | Onsenal | Pharmacia-Pfizer EEIG Hillbottom Road High Wycombe Bucks HP12 4PX United Kingdom | Pharmacia-Pfizer EEIG | Hillbottom Road |
| Pharmacia-Pfizer EEIG | | | | |
| Hillbottom Road | | | | |
| High Wycombe | | | | |
| Bucks HP12 4PX | | | | |
| United Kingdom | | | | |
| 22.04.2004 | Kudeq | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited Sandwich | Kent CT13 9NJ |
| Pfizer Limited Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 22.04.2004 | Bextra | Pharmacia-Pfizer EEIG Hillbottom Road High Wycombe Bucks HP12 4PX United Kingdom | Pharmacia-Pfizer EEIG | Hillbottom Road |
| Pharmacia-Pfizer EEIG | | | | |
| Hillbottom Road | | | | |
| High Wycombe | | | | |
| Bucks HP12 4PX | | | | |
| United Kingdom | | | | |
| 22.04.2004 | Dynastat | Pharmacia Europe EEIG Hillbottom Road High Wycombe Buckinghamshire HP12 4PX United Kingdom | Pharmacia Europe EEIG | Hillbottom Road |
| Pharmacia Europe EEIG | | | | |
| Hillbottom Road | | | | |
| High Wycombe | | | | |
| Buckinghamshire HP12 4PX | | | | |
| United Kingdom | | | | |
| 22.04.2004 | Rayzon | Pharmacia Europe EEIG Hillbottom Road High Wycombe Buckinghamshire HP12 4PX United Kingdom | Pharmacia Europe EEIG | Hillbottom Road |
| Pharmacia Europe EEIG | | | | |
| Hillbottom Road | | | | |
| High Wycombe | | | | |
| Buckinghamshire HP12 4PX | | | | |
| United Kingdom | | | | |
| 28.04.2004 | Zerit | Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG | 141-149 Staines Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| 141-149 Staines Road | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 28.04.2004 | Viracept | Roche Registration Limited 40 Broadwater Road Welwyn Garden City Hertfordshire AL7 3AY United Kingdom | Roche Registration Limited | 40 Broadwater Road |
| Roche Registration Limited | | | | |
| 40 Broadwater Road | | | | |
| Welwyn Garden City | | | | |
| Hertfordshire AL7 3AY | | | | |
| United Kingdom | | | | |
| 29.04.2004 | 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 | | | | |
| 29.04.2004 | Sustiva | Bristol-Myers Squibb Pharma EEIG 141-149 Staines Road Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG | 141-149 Staines Road |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| 141-149 Staines Road | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 07.05.2004 | Ferriprox | Apotex Europe Ltd Rowan House 41 London Street Reading Berkshire RG1 4PS United Kingdom | Apotex Europe Ltd | Rowan House |
| Apotex Europe Ltd | | | | |
| Rowan House | | | | |
| 41 London Street | | | | |
| Reading | | | | |
| Berkshire RG1 4PS | | | | |
| United Kingdom | | | | |
| 10.05.2004 | Enbrel | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom | Wyeth Europa Limited | Huntercombe Lane |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| 11.05.2004 | Cancidas | 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 | | | | |
| 13.05.2004 | Cancidas | 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 | | | | |

Issuing of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93) 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 |
| ------------------------- | ----------------------------- | --------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 07.05.2004 | Equilis StrepE | Intervet International BV Wim de Körverstraat, 35 5831 AN Boxmeer Nederland | Intervet International BV | Wim de Körverstraat, 35 |
| Intervet International BV | | | | |
| Wim de Körverstraat, 35 | | | | |
| 5831 AN Boxmeer | | | | |
| Nederland | | | | |

Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93) 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 |
| ------------------------ | ----------------------------- | ------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 28.04.2004 | SevoFlo | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 28.04.2004 | Locatim | Biokema Anstalt Aeulestrasse 38 9490 Vaduz Fürstentum Liechtenstein | Biokema Anstalt | Aeulestrasse 38 |
| Biokema Anstalt | | | | |
| Aeulestrasse 38 | | | | |
| 9490 Vaduz | | | | |
| Fürstentum Liechtenstein | | | | |

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 Agency for the Evaluation of Medicinal products |
| ------------------------------------------------------------ |
| 7, Westferry Circus, Canary Wharf |
| LONDON E14 4HB |
| United Kingdom |

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( 1 )  OJ L 214 du 24 August 1993, page 1.

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