# C_2006078EN.01001501.xml

| 31.3.2006 | EN | Official Journal of the European Union | C 78/15 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2006 to 28 February 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 78/03)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| ------------------------------ | ----------------------------- | ----------------------------------------- | -------------------------------------------------------------------- | --------------------------------------------- | -------------------- | ------------------------------------------------ | -------------------- |
| 15.2.2006 | Neupro | Rotigotine | Schwarz Pharma Ltd Shannon Industrial Estate Co.Clare Ireland | Schwarz Pharma Ltd | Shannon | Industrial Estate | Co.Clare |
| Schwarz Pharma Ltd | | | | | | | |
| Shannon | | | | | | | |
| Industrial Estate | | | | | | | |
| Co.Clare | | | | | | | |
| Ireland | | | | | | | |
| 21.2.2006 | Rotarix | Rotavirus vaccine, live | GlaxoSmithKline Biologicals SA rue de l'Institut 89 B-1330 Rixensart | GlaxoSmithKline Biologicals SA | rue de l'Institut 89 | B-1330 Rixensart | EU/1/05/330/001-004 |
| GlaxoSmithKline Biologicals SA | | | | | | | |
| rue de l'Institut 89 | | | | | | | |
| B-1330 Rixensart | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------- |
| 2.2.2006 | Fareston | Orion Corporation Orionintie 1 FIN-02200 Espoo | Orion Corporation | Orionintie 1 |
| Orion Corporation | | | | |
| Orionintie 1 | | | | |
| FIN-02200 Espoo | | | | |
| 9.2.2006 | NovoSeven | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 9.2.2006 | Aerius | Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles | Schering Plough Europe | Rue de Stalle, 73, Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, Stallestraat, 73 | | | | |
| B-1180 Brussel/Bruxelles | | | | |
| 9.2.2006 | Neoclarityn | Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles | Schering Plough Europe | Rue de Stalle, 73, Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, Stallestraat, 73 | | | | |
| B-1180 Brussel/Bruxelles | | | | |
| 9.2.2006 | Azomyr | Schering Plough Europe Rue de Stalle, 73, Stallestraat, 73 B-1180 Brussel/Bruxelles | Schering Plough Europe | Rue de Stalle, 73, Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, Stallestraat, 73 | | | | |
| B-1180 Brussel/Bruxelles | | | | |
| 9.2.2006 | Humalog | 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 | | | | |
| 9.2.2006 | Xeloda | 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 | | | | |
| 9.2.2006 | Replagal | TKT Europe AB Rinkebyvägen 11B S-182 36 Danderyd | TKT Europe AB | Rinkebyvägen 11B |
| TKT Europe AB | | | | |
| Rinkebyvägen 11B | | | | |
| S-182 36 Danderyd | | | | |
| 9.2.2006 | Fasturtec | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 9.2.2006 | Kepivance | Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland | Amgen Europe BV | Minervum 7061 |
| Amgen Europe BV | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 13.2.2006 | Metalyse | 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 | | | | |
| 13.2.2006 | Fabrazyme | Genzyme Europe BV Gooimeer 10 Naarden 1411 DD Nederland | Genzyme Europe BV | Gooimeer 10 |
| Genzyme Europe BV | | | | |
| Gooimeer 10 | | | | |
| Naarden 1411 DD | | | | |
| Nederland | | | | |
| 13.2.2006 | 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 | | | | |
| 13.2.2006 | InductOs | 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 | | | | |
| 13.2.2006 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk | | | | |
| F-69007 Lyon | | | | |
| 14.2.2006 | Insuman | Aventis Pharma Deutschland GmbH Brueningstraße 50 D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH | Brueningstraße 50 |
| Aventis Pharma Deutschland GmbH | | | | |
| Brueningstraße 50 | | | | |
| D-65926 Frankfurt am Main | | | | |
| 14.2.2006 | Tasmar | Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford lane Basingstoke RG24 8WD United Kingdom | Valeant Pharmaceuticals Limited | Cedarwood |
| Valeant Pharmaceuticals Limited | | | | |
| Cedarwood | | | | |
| Chineham Business Park | | | | |
| Crockford lane | | | | |
| Basingstoke RG24 8WD | | | | |
| United Kingdom | | | | |
| 17.2.2006 | Pritor | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.2.2006 | Viracept | 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 | | | | |
| 28.2.2006 | Parareg | Dompé Biotec SpA Via San Martino, 12 I-20122 Milano | Dompé Biotec SpA | Via San Martino, 12 |
| Dompé Biotec SpA | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 28.2.2006 | Truvada | Gilead Sciences International Limited Granta Park Abington Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited | Granta Park Abington Cambridge |
| Gilead Sciences International Limited | | | | |
| Granta Park Abington Cambridge | | | | |
| CB1 6GT | | | | |
| United Kingdom | | | | |
| 28.2.2006 | 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 | | | | |
| 28.2.2006 | 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 | | | | |
| 28.2.2006 | Aranesp | Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland | Amgen Europe BV | Minervum 7061 |
| Amgen Europe BV | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 28.2.2006 | Lysodren | Laboratoire HRA Pharma 19 rue Frédérick Lemaître F-75020 Paris | Laboratoire HRA Pharma | 19 rue Frédérick Lemaître |
| Laboratoire HRA Pharma | | | | |
| 19 rue Frédérick Lemaître | | | | |
| F-75020 Paris | | | | |
| 28.2.2006 | 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 | | | | |
| 28.2.2006 | 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 | | | | |
| 28.2.2006 | Exelon | 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 | | | | |
| 28.2.2006 | 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 | | | | |
| 28.2.2006 | Telzir | Glaxo Group Ltd Greenford Road, Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford Road, Greenford |
| Glaxo Group Ltd | | | | |
| Greenford Road, Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 28.2.2006 | Nespo | Dompé Biotec SpA Via San Martino, 12 I-20122 Milano | Dompé Biotec SpA | Via San Martino, 12 |
| Dompé Biotec SpA | | | | |
| Via San Martino, 12 | | | | |
| I-20122 Milano | | | | |
| 28.2.2006 | Rapamune | 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 | | | | |
| 28.2.2006 | Mimpara | Amgen Europe BV Minervum 7061 4817 ZK Breda Nederland | Amgen Europe BV | Minervum 7061 |
| Amgen Europe BV | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| Nederland | | | | |
| 28.2.2006 | Remicade | Centocor BV Einsteinweg 101 2333 CB Leiden Nederland | Centocor BV | Einsteinweg 101 |
| Centocor BV | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| Nederland | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

| 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 |
| --------------------- | ----------------------------- | --------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 2.2.2006 | Theryttrex | MDS Nordion SA Zoning Industriel B-6220 Fleurus | MDS Nordion SA | Zoning Industriel |
| MDS Nordion SA | | | | |
| Zoning Industriel | | | | |
| B-6220 Fleurus | | | | |
| 2.2.2006 | Daquiran | Dr. Karl Thomae GmbH Birkendorfferstr. 65 D-88397 Biberach/Riss | Dr. Karl Thomae GmbH | Birkendorfferstr. 65 |
| Dr. Karl Thomae GmbH | | | | |
| Birkendorfferstr. 65 | | | | |
| D-88397 Biberach/Riss | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| ---------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------- |
| 2.2.2006 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road New Malden Surrey KT3 4QS |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road New Malden Surrey KT3 4QS | | | | |
| United Kingdom | | | | |
| 3.2.2006 | Econor | Novartis Animal Health Austria GmbH Biochemiestraße 10 A-6250 Kundl | Novartis Animal Health Austria GmbH | Biochemiestraße 10 |
| Novartis Animal Health Austria GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 8.2.2006 | Porcilis AR-T DF | 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 | | | | |
| 8.2.2006 | Pirsue | 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 | | | | |
| 13.2.2006 | ProteqFlu Te | Merial 29 Avenue Tony Garnier F-69007 Lyon | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 13.2.2006 | Advasure | 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 | | | | |
| 13.2.2006 | ProteqFlu | Merial 29 avenue Tony Garnier F-69007 Lyon | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 28.2.2006 | Stronghold | PFIZER Ltd
Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom | Ramsgate Road | Sandwich |
| 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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