# C_2004166EN.01000201.xml

| 25.6.2004 | EN | Official Journal of the European Union | C 166/2 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15/05/2004 to 15/06/2004

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

(2004/C 166/02)

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 |
| --------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- |
| 01.06.2004 | Levemir | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, | Novo Nordisk A/S, | Novo Allé, |
| Novo Nordisk A/S, | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| 04.06.2004 | Abilifly | Otsuka Pharmaceutical Europe Ltd, Common-wealth House, 2 Chalkhill Road, Hammersmith, London W6 8DW, United Kingdom | Otsuka Pharmaceutical Europe Ltd, | Common-wealth House, |
| Otsuka Pharmaceutical Europe Ltd, | | | | |
| Common-wealth House, | | | | |
| 2 Chalkhill Road, | | | | |
| Hammersmith, | | | | |
| London W6 8DW, | | | | |
| United Kingdom | | | | |
| 08.06.2004 | TachoSil | Nycomed Austria GMBH, St.-Peter-Strasse 25, A-4020 Linz, | Nycomed Austria GMBH, | St.-Peter-Strasse 25, |
| Nycomed Austria GMBH, | | | | |
| St.-Peter-Strasse 25, | | | | |
| A-4020 Linz, | | | | |
| 15.06.2004 | Oxybutynin | Nicobrand Limited, 189 Casteroe Road, Coleraine, Northerne Ireland | Nicobrand Limited, | 189 Casteroe Road, |
| Nicobrand Limited, | | | | |
| 189 Casteroe Road, | | | | |
| Coleraine, | | | | |
| Northerne Ireland | | | | |

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 |
| -------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 19.05.2004 | Protopic | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München, | Fujisawa GmbH, | Neumarkter Str. 61, |
| Fujisawa GmbH, | | | | |
| Neumarkter Str. 61, | | | | |
| D-81673 München, | | | | |
| 25.05.2004 | Hepsera | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited, | Cambridge CB1 6GT |
| Gilead Sciences International Limited, | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 26.05.2004 | Viagra | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited, | Sandwich, |
| Pfizer Limited, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 26.05.2004 | Combivir | 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 | | | | |
| 26.05.2004 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 26.05.2004 | Taxotere | Aventis Pharma S.A., 20 avenue Raymond Aron, 92165 Antony Cedex, France | Aventis Pharma S.A., | 20 avenue Raymond Aron, |
| Aventis Pharma S.A., | | | | |
| 20 avenue Raymond Aron, | | | | |
| 92165 Antony Cedex, France | | | | |
| 26.05.2004 | TRIZIVIR | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 01.06.2004 | Vivanza | Bayer AG, D-51368 Leverkusen, | Bayer AG, | D-51368 Leverkusen, |
| Bayer AG, | | | | |
| D-51368 Leverkusen, | | | | |
| 01.06.2004 | Levitra | Bayer AG, D-51368 Leverkusen, | Bayer AG, | D-51368 Leverkusen, |
| Bayer AG, | | | | |
| D-51368 Leverkusen, | | | | |
| 01.06.2004 | Epivir | 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 | | | | |
| 08.06.2004 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | Centocor B.V., | Einsteinweg 101, |
| Centocor B.V., | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 08.06.2004 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | Centocor B.V., | Einsteinweg 101, |
| Centocor B.V., | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 08.06.2004 | Fuzeon | 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 | | | | |
| 08.06.2004 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main, | Aventis Pharma Deutschland GmbH, | D-65926 Frankfurt am Main, |
| Aventis Pharma Deutschland GmbH, | | | | |
| D-65926 Frankfurt am Main, | | | | |
| 08.06.2004 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited, | Sandwich, |
| Pfizer Limited, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 09.06.2004 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited, | Sandwich, |
| Pfizer Limited, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.06.2004 | Arava | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main, | Aventis Pharma Deutschland GmbH, | D-65926 Frankfurt am Main, |
| Aventis Pharma Deutschland GmbH, | | | | |
| D-65926 Frankfurt am Main, | | | | |
| 10.06.2004 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited, | Cambridge CB1 6GT |
| Gilead Sciences International Limited, | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 10.06.2004 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited, | Cambridge CB1 6GT |
| Gilead Sciences International Limited, | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 10.06.2004 | Herceptin | 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 | | | | |
| 10.06.2004 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | Abbott Laboratories Ltd., | Queenborough, |
| Abbott Laboratories Ltd., | | | | |
| Queenborough, | | | | |
| Kent ME11 5EL, | | | | |
| United Kingdom | | | | |
| 10.06.2004 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | Abbott Laboratories Ltd., | Queenborough, |
| Abbott Laboratories Ltd., | | | | |
| Queenborough, | | | | |
| Kent ME11 5EL, | | | | |
| United Kingdom | | | | |
| 15.06.2004 | Xigris | 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 | | | | |

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