# C_2008104EN.01000701.xml

| 25.4.2008 | EN | Official Journal of the European Union | C 104/7 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 1 )
)

(2008/C 104/05)

—   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 |
| --------------------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 18.3.2008 | Pradaxa | dabigatran etexilate mesilate | Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH | Binger Strasse 173 | D-55216 Ingelheim am Rhein | EU/1/08/442/001-008 |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Strasse 173 | | | | | | | |
| D-55216 Ingelheim am Rhein | | | | | | | |

—   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 |
| --------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------- | ---------------------------------- |
| 3.3.2008 | Noxafil | SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | SP Europe | Rue de Stalle, 73/Stallestraat, 73 |
| SP Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 3.3.2008 | Posacozanole SP | SP Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | SP Europe | Rue de Stalle, 73/Stallestraat, 73 |
| SP Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 3.3.2008 | 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 | | | | |
| 3.3.2008 | 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 | | | | |
| 3.3.2008 | 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 | | | | |
| 3.3.2008 | Avonex | Biogen Idec Ltd, 5 Roxborough Way Foundation Park Maidenhead Berkshire SL6 3UD United Kindgom | Biogen Idec Ltd, 5 Roxborough Way | Foundation Park |
| Biogen Idec Ltd, 5 Roxborough Way | | | | |
| Foundation Park | | | | |
| Maidenhead | | | | |
| Berkshire SL6 3UD | | | | |
| United Kindgom | | | | |
| 5.3.2008 | MIRCERA | 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 | | | | |
| 5.3.2008 | 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 | | | | |
| 5.3.2008 | Cholestagel | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden Nederland | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| Nederland | | | | |
| 11.3.2008 | Helicobacter Test INFAI | INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH Universitätsstrasse 142 D-44799 Bochum | INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH | Universitätsstrasse 142 |
| INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH | | | | |
| Universitätsstrasse 142 | | | | |
| D-44799 Bochum | | | | |
| 17.3.2008 | Vivanza | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 17.3.2008 | Visudyne | 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 | | | | |
| 17.3.2008 | Cialis | 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 | | | | |
| 17.3.2008 | Levitra | Bayer AG D-51368 Leverkusen | Bayer AG | D-51368 Leverkusen |
| Bayer AG | | | | |
| D-51368 Leverkusen | | | | |
| 17.3.2008 | Mimpara | 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 | | | | |
| 17.3.2008 | Parareg | 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 | | | | |
| 17.3.2008 | 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 | | | | |
| 17.3.2008 | Viagra | Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 18.3.2008 | Omnitrope | Sandoz GmbH Biochemiestraße 10 A-6250 Kundl | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| A-6250 Kundl | | | | |
| 18.3.2008 | Zavesca | 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 | | | | |
| 18.3.2008 | 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 | | | | |
| 18.3.2008 | Kaletra | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 18.3.2008 | Hepsera | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 18.3.2008 | Revlimid | Celgene Europe Limited 8 The Square Stockley Park Uxbridge Middlesex UB11 1FW United Kingdom | Celgene Europe Limited | 8 The Square |
| Celgene Europe Limited | | | | |
| 8 The Square | | | | |
| Stockley Park | | | | |
| Uxbridge | | | | |
| Middlesex UB11 1FW | | | | |
| United Kingdom | | | | |
| 19.3.2008 | Arixtra | 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 | | | | |
| 27.3.2008 | 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 | | | | |
| 27.3.2008 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 27.3.2008 | Tygacil | 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 | | | | |
| 27.3.2008 | 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 | | | | |
| 27.3.2008 | Norvir | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 27.3.2008 | Lyrica | 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 | | | | |
| 27.3.2008 | Xeloda | 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 | | | | |
| 27.3.2008 | Optimark | Tyco Healthcare Deutschland GmbH Gewerbepark 1 D-93333 Neustadt/Donau | Tyco Healthcare Deutschland GmbH | Gewerbepark 1 |
| Tyco Healthcare Deutschland GmbH | | | | |
| Gewerbepark 1 | | | | |
| D-93333 Neustadt/Donau | | | | |
| 31.3.2008 | Neoclarityn | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 31.3.2008 | Azomyr | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 31.3.2008 | 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 | | | | |
| 31.3.2008 | DuoTrav | Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom | Alcon Laboratories (UK) Ltd | Pentagon Park |
| Alcon Laboratories (UK) Ltd | | | | |
| Pentagon Park | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts HP2 7UD | | | | |
| United Kingdom | | | | |
| 31.3.2008 | Optisulin | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main | | | | |
| 31.3.2008 | 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 | | | | |
| 31.3.2008 | Zonegran | Eisai Limited 3 Shortlands London W6 8EE United Kingdom | Eisai Limited | 3 Shortlands |
| Eisai Limited | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 31.3.2008 | Aerius | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/B-1180 Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/B-1180 Brussel | | | | |
| 31.3.2008 | Tandemact | Takeda Global Research and Development Centre (Europe) Ltd Arundel Great Court 2 Arundel Street London WC2R 3DA United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | Arundel Great Court |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| Arundel Great Court | | | | |
| 2 Arundel Street | | | | |
| London WC2R 3DA | | | | |
| United Kingdom | | | | |

—   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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 11.3.2008 | Quixidar | 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 | | | | |

—   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 |
| ----------------------- | ----------------------------- | ----------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 5.3.2008 | SevoFlo | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 11.3.2008 | Neocolipor | Merial 29 Avenue Tony Garnier F-69007 Lyon | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 18.3.2008 | Stronghold | 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 | | | | |

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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