# C_2009231EN.01000301.xml

| 25.9.2009 | EN | Official Journal of the European Union | C 231/3 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 July 2009 to 31 July 2009

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

2009/C 231/03

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------------ | ----------------------------- | ---------------------------------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- | ----------------------------------------------- | -------------------- |
| 1.7.2009 | Ribavirin Teva Pharma BV | Ribavirin | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 2.7.2009 | Nymusa | Caffeine citrate | CHIESI FARMACEUTICI SpA Via Palermo 26/A 43100 Parma PR ITALIA | CHIESI FARMACEUTICI SpA | Via Palermo 26/A | 43100 Parma PR | ITALIA |
| CHIESI FARMACEUTICI SpA | | | | | | | |
| Via Palermo 26/A | | | | | | | |
| 43100 Parma PR | | | | | | | |
| ITALIA | | | | | | | |
| 20.7.2009 | Instanyl | Fentanyl | Nycomed Danmark ApS Langebjerg 1 4000 Roskilde DANMARK | Nycomed Danmark ApS | Langebjerg 1 | 4000 Roskilde | DANMARK |
| Nycomed Danmark ApS | | | | | | | |
| Langebjerg 1 | | | | | | | |
| 4000 Roskilde | | | | | | | |
| DANMARK | | | | | | | |
| 24.7.2009 | Vedrop | Tocofersolan | Orphan Europe SARL Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE | Orphan Europe SARL | Immeuble Le Wilson | 70 Avenue du Général de Gaulle | 92800 Puteaux |
| Orphan Europe SARL | | | | | | | |
| Immeuble Le Wilson | | | | | | | |
| 70 Avenue du Général de Gaulle | | | | | | | |
| 92800 Puteaux | | | | | | | |
| FRANCE | | | | | | | |
| 24.7.2009 | Topotecan Actavis | Topotecan | Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND | Actavis Group PTC ehf. | Reykjavikurvegi 76-78 | 220 Hafnarfjordur | ICELAND |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavikurvegi 76-78 | | | | | | | |
| 220 Hafnarfjordur | | | | | | | |
| ICELAND | | | | | | | |
| 28.7.2009 | Clopidogrel Acino | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.7.2009 | Clopidogrel ratiopharm GmbH | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.7.2009 | Clopidogrel 1A Pharma | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.7.2009 | Clopidogrel Hexal | Clopidogrel | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 | 83714 Miesbach | DEUTSCHLAND |
| Acino Pharma GmbH | | | | | | | |
| Am Windfeld 35 | | | | | | | |
| 83714 Miesbach | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 28.7.2009 | Grepid | Clopidogrel | Pharmathen S.A. 6 Dervenakion 15351 Pallini Attiki ΕΛΛAΔΑ | Pharmathen S.A. | 6 Dervenakion | 15351 Pallini Attiki | ΕΛΛAΔΑ |
| Pharmathen S.A. | | | | | | | |
| 6 Dervenakion | | | | | | | |
| 15351 Pallini Attiki | | | | | | | |
| ΕΛΛAΔΑ | | | | | | | |
| 28.7.2009 | Clopidogrel Teva | Clopidogrel | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 31.7.2009 | Mozobil | Plerixafor | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 | 1411 DD Naarden | NEDERLAND |
| Genzyme Europe B.V. | | | | | | | |
| Gooimeer 10 | | | | | | | |
| 1411 DD Naarden | | | | | | | |
| NEDERLAND | | | | | | | |

—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------ |
| 1.7.2009 | ReFacto AF | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 1.7.2009 | Cymbalta | 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 | | | | |
| 1.7.2009 | 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 | | | | |
| 1.7.2009 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue London WC2H 8HL UNITED KINGDOM | BioMarin Europe Ltd | 164 Shaftesbury Avenue |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue | | | | |
| London | | | | |
| WC2H 8HL | | | | |
| UNITED KINGDOM | | | | |
| 1.7.2009 | Integrilin | Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 ONN | | | | |
| UNITED KINGDOM | | | | |
| 1.7.2009 | Rebif | 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 | | | | |
| 1.7.2009 | ProQuad | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 1.7.2009 | Liprolog | 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 | | | | |
| 1.7.2009 | Norvir | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 1.7.2009 | Humalog | 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 | | | | |
| 1.7.2009 | Xeristar | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 1.7.2009 | 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 | | | | |
| 1.7.2009 | 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 | | | | |
| 1.7.2009 | Arava | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | 65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| 65926 Frankfurt am Main | | | | |
| DEUTSCHLAND | | | | |
| 2.7.2009 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| NEDERLAND | | | | |
| 2.7.2009 | Alimta | 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 | | | | |
| 2.7.2009 | 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 | | | | |
| 2.7.2009 | ADROVANCE | 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 | | | | |
| 2.7.2009 | Bonviva | 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 | | | | |
| 2.7.2009 | Bondenza | 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 | | | | |
| 2.7.2009 | Aldurazyme | 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 | | | | |
| 2.7.2009 | Angiox | The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM | The Medicines Company UK Ltd | 115 L Milton Park |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire | | | | |
| OX14 4SA | | | | |
| UNITED KINGDOM | | | | |
| 3.7.2009 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-La-Neuve BELGIQUE | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet 15 | | | | |
| 1348 Louvain-La-Neuve | | | | |
| BELGIQUE | | | | |
| 3.7.2009 | Remicade | Centocor B.V. Einsteinweg 101 2333 CB Leiden NEDERLAND | Centocor B.V. | Einsteinweg 101 |
| Centocor B.V. | | | | |
| Einsteinweg 101 | | | | |
| 2333 CB Leiden | | | | |
| NEDERLAND | | | | |
| 3.7.2009 | Zyprexa | 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 | | | | |
| 3.7.2009 | RELISTOR | Wyeth Europa Limited Huntercombe Lane South, Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Limited | Huntercombe Lane South, Taplow |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 7.7.2009 | 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 | | | | |
| 7.7.2009 | Zyprexa Velotab | 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 | | | | |
| 7.7.2009 | Prepandrix | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals S.A. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 7.7.2009 | Pre-pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals S.A. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 7.7.2009 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 7.7.2009 | YENTREVE | 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 | | | | |
| 7.7.2009 | 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 | | | | |
| 7.7.2009 | Zonegran | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Hertfordshire | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 7.7.2009 | CELSENTRI | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 7.7.2009 | Invega | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 7.7.2009 | 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 | | | | |
| 7.7.2009 | FOSAVANCE | 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 | | | | |
| 7.7.2009 | REYATAZ | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 7.7.2009 | Revatio | Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 10.7.2009 | Binocrit | Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH | Sandoz GmbH | Biochemiestrasse 10 |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| 6250 Kundl | | | | |
| ÖSTERREICH | | | | |
| 10.7.2009 | Pandemrix | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals S.A. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 10.7.2009 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND | Hexal AG. | Industriestrasse 25 |
| Hexal AG. | | | | |
| Industriestrasse 25 | | | | |
| 83607 Holzkirchen | | | | |
| DEUTSCHLAND | | | | |
| 14.7.2009 | INCRELEX | Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Tercica Europe Limited Riverside One, Sir John Rogerson's Quay Dublin 2 IRELAND | Ipsen Pharma | 65 quai Georges Gorse |
| Ipsen Pharma | | | | |
| 65 quai Georges Gorse | | | | |
| 92100 Boulogne-Billancourt | | | | |
| FRANCE | | | | |
| Tercica Europe Limited | | | | |
| Riverside One, Sir John Rogerson's Quay | | | | |
| Dublin 2 | | | | |
| IRELAND | | | | |
| 14.7.2009 | 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 | | | | |
| 14.7.2009 | Exjade | 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 | | | | |
| 14.7.2009 | ISENTRESS | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Limited | Hertford Road |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 14.7.2009 | Thelin | Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ UNITED KINGDOM | Encysive (UK) Limited | Alder Castle House |
| Encysive (UK) Limited | | | | |
| Alder Castle House | | | | |
| 10 Noble Street | | | | |
| London | | | | |
| EC2V 7QJ | | | | |
| UNITED KINGDOM | | | | |
| 14.7.2009 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37 | | | | |
| 58638 Iserlohn | | | | |
| DEUTSCHLAND | | | | |
| 14.7.2009 | Dynastat | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 14.7.2009 | DULOXETINE BOEHRINGER INGELHEIM | Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Strasse 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 14.7.2009 | Doribax | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 14.7.2009 | Crixivan | 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 | | | | |
| 14.7.2009 | Paxene | Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ UNITED KINGDOM | Norton Healthcare Limited | Albert Basin |
| Norton Healthcare Limited | | | | |
| Albert Basin | | | | |
| Royal Docks | | | | |
| London | | | | |
| E16 2QJ | | | | |
| UNITED KINGDOM | | | | |
| 16.7.2009 | Neupro | Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND | Schwarz Pharma Ltd | Shannon |
| Schwarz Pharma Ltd | | | | |
| Shannon | | | | |
| Industrial Estate | | | | |
| Co. Clare | | | | |
| IRELAND | | | | |
| 16.7.2009 | Opgenra | Howmedica International S. de R. L. Raheen Business Park Limerick IRELAND | Howmedica International S. de R. L. | Raheen Business Park |
| Howmedica International S. de R. L. | | | | |
| Raheen Business Park | | | | |
| Limerick | | | | |
| IRELAND | | | | |
| 16.7.2009 | ADROVANCE | 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 | | | | |
| 16.7.2009 | ECALTA | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 16.7.2009 | ISENTRESS | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Limited | Hertford Road |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 16.7.2009 | CUBICIN | 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 | | | | |
| 16.7.2009 | Olanzapine Neopharma | Neopharma Limited 57 High Street Odiham Hampshire RG29 1LF UNITED KINGDOM | Neopharma Limited | 57 High Street |
| Neopharma Limited | | | | |
| 57 High Street | | | | |
| Odiham | | | | |
| Hampshire | | | | |
| RG29 1LF | | | | |
| UNITED KINGDOM | | | | |
| 16.7.2009 | Enbrel | 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 | | | | |
| 17.7.2009 | Zalasta | Krka d.d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | Krka d.d. | Novo mesto |
| Krka d.d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SI-8501 Novo mesto | | | | |
| SLOVENIJA | | | | |
| 17.7.2009 | 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 | | | | |
| 17.7.2009 | Olanzapine Mylan | Generics (UK) Limited Station Close Potters Bar Hertfordshire EN6 1TL UNITED KINGDOM | Generics (UK) Limited | Station Close |
| Generics (UK) Limited | | | | |
| Station Close | | | | |
| Potters Bar | | | | |
| Hertfordshire | | | | |
| EN6 1TL | | | | |
| UNITED KINGDOM | | | | |
| 20.7.2009 | Olanzapine Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| 23.7.2009 | Dynastat | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 23.7.2009 | NeuroBloc | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Hertfordshire | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 23.7.2009 | Xelevia | 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 | | | | |
| 23.7.2009 | 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 | | | | |
| 23.7.2009 | Invanz | 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 | | | | |
| 23.7.2009 | ATryn | GTC Biotherapeutics UK Limited 10 Norwich Street London EC4A 1BD UNITED KINGDOM LEO Pharma A/S Industriparken 55 2750 Ballerup DANMARK | GTC Biotherapeutics UK Limited | 10 Norwich Street |
| GTC Biotherapeutics UK Limited | | | | |
| 10 Norwich Street | | | | |
| London | | | | |
| EC4A 1BD | | | | |
| UNITED KINGDOM | | | | |
| LEO Pharma A/S | | | | |
| Industriparken 55 | | | | |
| 2750 Ballerup | | | | |
| DANMARK | | | | |
| 23.7.2009 | Avastin | 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 | | | | |
| 23.7.2009 | Vistide | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 23.7.2009 | ECALTA | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 24.7.2009 | Vimpat | UCB Pharma S.A. Allée de la Recherche 60 1070 Bruxelles BELGIQUE | UCB Pharma S.A. | Allée de la Recherche 60 |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60 | | | | |
| 1070 Bruxelles | | | | |
| BELGIQUE | | | | |
| 24.7.2009 | Humira | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 24.7.2009 | ZYPADHERA | 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 | | | | |
| 24.7.2009 | Macugen | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 24.7.2009 | Silgard | 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 | | | | |
| 24.7.2009 | Flebogammadif | Instituto Grifols S.A. Can Guasch Parets del Vallès 08150 Barcelona ESPAÑA | Instituto Grifols S.A. | Can Guasch |
| Instituto Grifols S.A. | | | | |
| Can Guasch | | | | |
| Parets del Vallès | | | | |
| 08150 Barcelona | | | | |
| ESPAÑA | | | | |
| 24.7.2009 | FABLYN | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 24.7.2009 | Nexavar | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 24.7.2009 | FIRMAGON | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 København S DANMARK | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11 |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11 | | | | |
| 2300 København S | | | | |
| DANMARK | | | | |
| 24.7.2009 | 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 | | | | |
| 24.7.2009 | Cervarix | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals S.A. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 24.7.2009 | Kuvan | Merck KGaA Frankfurter Straße 250 64293 Darmstadt DEUTSCHLAND | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| 64293 Darmstadt | | | | |
| DEUTSCHLAND | | | | |
| 24.7.2009 | Gardasil | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 24.7.2009 | Pedea | Orphan Europe SARL Immeuble Le Wilson 70 Avenue du Général de Gaulle 92800 Puteaux FRANCE | Orphan Europe SARL | Immeuble Le Wilson |
| Orphan Europe SARL | | | | |
| Immeuble Le Wilson | | | | |
| 70 Avenue du Général de Gaulle | | | | |
| 92800 Puteaux | | | | |
| FRANCE | | | | |
| 27.7.2009 | Synagis | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent | | | | |
| ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 27.7.2009 | Tasigna | 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 | | | | |
| 27.7.2009 | Luminity | Lantheus MI UK Limited One South Place London EC2M 2WG UNITED KINGDOM Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe/Terhulpsesteenweg 185 1170 Brussels/Brussel BELGIQUE/BELGIË | Lantheus MI UK Limited | One South Place |
| Lantheus MI UK Limited | | | | |
| One South Place | | | | |
| London | | | | |
| EC2M 2WG | | | | |
| UNITED KINGDOM | | | | |
| Bristol-Myers Squibb Pharma Belgium Sprl | | | | |
| Chaussée de la Hulpe/Terhulpsesteenweg 185 | | | | |
| 1170 Brussels/Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 27.7.2009 | NovoRapid | Novo Nordisk A/S Novo Allé 2880 Bagsværd DANMARK | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| 2880 Bagsværd | | | | |
| DANMARK | | | | |
| 27.7.2009 | Xolair | 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 | | | | |
| 27.7.2009 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-La-Neuve BELGIQUE | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet 15 | | | | |
| 1348 Louvain-La-Neuve | | | | |
| BELGIQUE | | | | |
| 27.7.2009 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 27.7.2009 | KOGENATE Bayer | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 27.7.2009 | ViraferonPeg | Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Schering Plough Europe | Rue de Stalle 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 27.7.2009 | Renagel | 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 | | | | |
| 28.7.2009 | Osseor | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 28.7.2009 | Protelos | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 28.7.2009 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 29.7.2009 | Ebixa | H.Lundbeck A/S Ottiliavej 9 2500 Valby DANMARK | H.Lundbeck A/S | Ottiliavej 9 |
| H.Lundbeck A/S | | | | |
| Ottiliavej 9 | | | | |
| 2500 Valby | | | | |
| DANMARK | | | | |
| 29.7.2009 | Januvia | 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 | | | | |
| 29.7.2009 | Firazyr | Jerini AG Invalidenstr. 130 10115 Berlin DEUTSCHLAND | Jerini AG | Invalidenstr. 130 |
| Jerini AG | | | | |
| Invalidenstr. 130 | | | | |
| 10115 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 29.7.2009 | NutropinAq | Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE IPSEN Limited 190 Bath Road Slough Berkshire SLI 3XE UNITED KINGDOM | Ipsen Pharma | 65 quai Georges Gorse |
| Ipsen Pharma | | | | |
| 65 quai Georges Gorse | | | | |
| 92100 Boulogne-Billancourt | | | | |
| FRANCE | | | | |
| IPSEN Limited | | | | |
| 190 Bath Road | | | | |
| Slough | | | | |
| Berkshire | | | | |
| SLI 3XE | | | | |
| UNITED KINGDOM | | | | |
| 29.7.2009 | Abraxane | Abraxis BioScience Limited Hatfield AL10 9NA UNITED KINGDOM | Abraxis BioScience Limited | Hatfield |
| Abraxis BioScience Limited | | | | |
| Hatfield | | | | |
| AL10 9NA | | | | |
| UNITED KINGDOM | | | | |
| 29.7.2009 | Janumet | 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 | | | | |
| 29.7.2009 | Velmetia | 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 | | | | |
| 29.7.2009 | Efficib | 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 | | | | |
| 29.7.2009 | IVEMEND | 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 | | | | |
| 29.7.2009 | TOVIAZ | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 31.7.2009 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104 60318 Frankfurt/Main DEUTSCHLAND | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104 |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104 | | | | |
| 60318 Frankfurt/Main | | | | |
| DEUTSCHLAND | | | | |
| 31.7.2009 | Emselex | 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 | | | | |
| 31.7.2009 | Kepivance | Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE | Biovitrum AB (publ) | SE-112 76 Stockholm |
| Biovitrum AB (publ) | | | | |
| SE-112 76 Stockholm | | | | |
| SVERIGE | | | | |
| 31.7.2009 | EMEND | 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 authorisation (Article 38 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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------------- | ----------------------------- | ------------------------------------------------------------ | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ----------------------------------------------- | -------------------- |
| 7.7.2009 | Melovem | Meloxicam | Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer NEDERLAND | Dopharma Research B.V. | Zalmweg 24 | 4941 VX Raamsdonksveer | NEDERLAND |
| Dopharma Research B.V. | | | | | | | |
| Zalmweg 24 | | | | | | | |
| 4941 VX Raamsdonksveer | | | | | | | |
| NEDERLAND | | | | | | | |
| 24.7.2009 | Suvaxyn PCV | Porcine Circovirus recombinant virus (cPCV) 1-2, inactivated | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM | Fort Dodge Animal Health Ltd | Flanders Road | Hedge End | Southampton |
| Fort Dodge Animal Health Ltd | | | | | | | |
| Flanders Road | | | | | | | |
| Hedge End | | | | | | | |
| Southampton | | | | | | | |
| SO30 4QH | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 14.7.2009 | Meloxivet | Janssen Pharmaceutica N.V. Turnhoutseweg 30 2340 Beerse BELGIË | Janssen Pharmaceutica N.V. | Turnhoutseweg 30 |
| Janssen Pharmaceutica N.V. | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 16.7.2009 | Nobivac Piro | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| NEDERLAND | | | | |
| 20.7.2009 | PRILACTONE | Ceva sante animale Z.I. la Ballastière 33500 Libourne FRANCE | Ceva sante animale | Z.I. la Ballastière |
| Ceva sante animale | | | | |
| Z.I. la Ballastière | | | | |
| 33500 Libourne | | | | |
| FRANCE | | | | |
| 20.7.2009 | ZACTRAN | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 31.7.2009 | Nobilis Influenza H7N1 | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| NEDERLAND | | | | |

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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