# C_2009048EN.01000401.xml

| 27.2.2009 | EN | Official Journal of the European Union | C 48/4 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2009 to 31 January 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 48/04)

—   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 |
| ------------------------------ | ----------------------------- | ------------------------------------------ | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------------- |
| 16.1.2009 | RoActemra | Tocilizumab | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom | Roche Registration Limited | 6 Falcon Way | Shire Park | Welwyn Garden City AL7 1TW |
| Roche Registration Limited | | | | | | | |
| 6 Falcon Way | | | | | | | |
| Shire Park | | | | | | | |
| Welwyn Garden City AL7 1TW | | | | | | | |
| United Kingdom | | | | | | | |
| 16.1.2009 | Rasilez HCT | Aliskiren hemifumarate/hydrochlorothiazide | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom | Novartis Europharm Limited | Wimblehurst Road | Horsham | West Sussex RH12 5AB |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road | | | | | | | |
| Horsham | | | | | | | |
| West Sussex RH12 5AB | | | | | | | |
| United Kingdom | | | | | | | |
| 16.1.2009 | STELARA | Ustekinumab | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 | B-2340 Beerse | EU/1/08/494/001-002 |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg, 30 | | | | | | | |
| B-2340 Beerse | | | | | | | |

—   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 |
| ------------------------------------------ | ----------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------------ |
| 5.1.2009 | 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 | | | | |
| 5.1.2009 | Irbesartan HCT BMS | 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 | | | | |
| 6.1.2009 | 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 | | | | |
| 6.1.2009 | Prevenar | Wyeth-Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-La-Neuve | Wyeth-Lederle Vaccines S.A. | Rue du Bosquet, 15 |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Rue du Bosquet, 15 | | | | |
| B-1348 Louvain-La-Neuve | | | | |
| 6.1.2009 | 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 | | | | |
| 7.1.2009 | 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 | | | | |
| 7.1.2009 | Irbesartan HCT Winthrop | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 7.1.2009 | Levemir | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |
| 7.1.2009 | Zevalin | Bayer Schering Pharma AG D-13342 Berlin | Bayer Schering Pharma AG | D-13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin | | | | |
| 7.1.2009 | 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 | | | | |
| 7.1.2009 | TORISEL | 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 | | | | |
| 7.1.2009 | Retacrit | HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp Nederland | HOSPIRA Enterprises B.V. | Taurusavenue 19-21b |
| HOSPIRA Enterprises B.V. | | | | |
| Taurusavenue 19-21b | | | | |
| 2132 LS Hoofddorp | | | | |
| Nederland | | | | |
| 7.1.2009 | BYETTA | 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 | | | | |
| 7.1.2009 | 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 | | | | |
| 9.1.2009 | 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 | | | | |
| 9.1.2009 | IntronA | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 9.1.2009 | Rilutek | Aventis Pharma S.A. 20, avenue Raymond Aron F-92160 Antony | Aventis Pharma S.A. | 20, avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20, avenue Raymond Aron | | | | |
| F-92160 Antony | | | | |
| 9.1.2009 | Xyrem | UCB Pharma Ltd 208 Bath Road Slough Berkshire SL1 3WE United Kingdom | UCB Pharma Ltd | 208 Bath Road |
| UCB Pharma Ltd | | | | |
| 208 Bath Road | | | | |
| Slough | | | | |
| Berkshire SL1 3WE | | | | |
| United Kingdom | | | | |
| 12.1.2009 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 12.1.2009 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 13.1.2009 | Emadine | 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 | | | | |
| 15.1.2009 | 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 | | | | |
| 16.1.2009 | Cyanokit | Merck Santé s.a.s. 37, rue Saint-Romain F-69379 Lyon Cedex 08 | Merck Santé s.a.s. | 37, rue Saint-Romain |
| Merck Santé s.a.s. | | | | |
| 37, rue Saint-Romain | | | | |
| F-69379 Lyon Cedex 08 | | | | |
| 16.1.2009 | 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 | | | | |
| 16.1.2009 | Regranex | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 20.1.2009 | Alli | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Limited | Berkeley Avenue |
| Glaxo Group Limited | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 20.1.2009 | Sebivo | 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 | | | | |
| 22.1.2009 | Temodal | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 B-1180 Bruxelles/Brussel | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 23.1.2009 | Tysabri | Elan Pharma International Ltd Monksland Athlone County Westmeath Ireland | Elan Pharma International Ltd | Monksland |
| Elan Pharma International Ltd | | | | |
| Monksland | | | | |
| Athlone | | | | |
| County Westmeath | | | | |
| Ireland | | | | |
| 26.1.2009 | Synagis | Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 26.1.2009 | Keppra | UCB Pharma S.A. Allée de la Recherche 60/Researchdreef, 60 B-1070 Bruxelles/Brussel | UCB Pharma S.A. | Allée de la Recherche 60/Researchdreef, 60 |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60/Researchdreef, 60 | | | | |
| B-1070 Bruxelles/Brussel | | | | |
| 26.1.2009 | Zostavax | 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 | | | | |
| 26.1.2009 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174, avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC | 174, avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 26.1.2009 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 26.1.2009 | 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 | | | | |
| 26.1.2009 | Prometax | 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 | | | | |
| 26.1.2009 | 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 | | | | |
| 26.1.2009 | Mirapexin | 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 | | | | |
| 26.1.2009 | Tamiflu | 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 | | | | |
| 27.1.2009 | Tritanrix HepB | GlaxoSmithKline Biologicals S.A. rue de l'Institut, 89 B-1330 Rixensart | GlaxoSmithKline Biologicals S.A. | rue de l'Institut, 89 |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut, 89 | | | | |
| B-1330 Rixensart | | | | |
| 27.1.2009 | 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 | | | | |
| 27.1.2009 | PritorPlus | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 27.1.2009 | 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 | | | | |
| 27.1.2009 | Viramune | 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 | | | | |
| 27.1.2009 | 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 | | | | |
| 27.1.2009 | Iscover | 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 | | | | |
| 27.1.2009 | Tarceva | 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 | | | | |
| 27.1.2009 | Invirase | 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 | | | | |
| 28.1.2009 | Diacomit | Biocodex 7, avenue Gallieni F-94250 Gentilly | Biocodex | 7, avenue Gallieni |
| Biocodex | | | | |
| 7, avenue Gallieni | | | | |
| F-94250 Gentilly | | | | |
| 29.1.2009 | Prezista | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 29.1.2009 | Aloxi | Helsinn Birex Pharmaceuticals Ltd Damastown Mulhuddart Dublin 15 Republic of Ireland | Helsinn Birex Pharmaceuticals Ltd | Damastown |
| Helsinn Birex Pharmaceuticals Ltd | | | | |
| Damastown | | | | |
| Mulhuddart | | | | |
| Dublin 15 | | | | |
| Republic of Ireland | | | | |
| 29.1.2009 | Kinzalkomb | Bayer HealthCare AG D-51368 Leverkusen | Bayer HealthCare AG | D-51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| D-51368 Leverkusen | | | | |
| 29.1.2009 | 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 | | | | |
| 30.1.2009 | 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 | | | | |
| 30.1.2009 | NeuroBloc | Eisai Limited 3, Shortlands London W6 8EE United Kingdom | Eisai Limited | 3, Shortlands |
| Eisai Limited | | | | |
| 3, Shortlands | | | | |
| London W6 8EE | | | | |
| United Kingdom | | | | |
| 30.1.2009 | Sifrol | 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 | | | | |
| 30.1.2009 | Thalidomide Celgene | Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA United Kingdom | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor SL4 1NA | | | | |
| 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 |
| --------------------- | ----------------------------- | -------------------------------------------------- | --------------------------------------------- | --------------------- |
| 16.1.2009 | Zimulti | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 16.1.2009 | ACOMPLIA | Sanofi-Aventis 174, avenue de France F-75013 Paris | Sanofi-Aventis | 174, avenue de France |
| Sanofi-Aventis | | | | |
| 174, avenue de France | | | | |
| F-75013 Paris | | | | |
| 30.1.2009 | Velosulin | Novo Nordisk A/S Novo Allé DK-2880 Bagsværd | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| DK-2880 Bagsværd | | | | |

—   Suspension of a marketing authorization (Article 20 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 |
| ------------------------------ | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 16.1.2009 | Ionsys | Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| B-2340 Beerse | | | | |

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
(Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 12.1.2009 | Porcilis PCV | Porcine circovirus type 2 ORF2 subunit antigen | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer Nederland | Intervet International B.V. | Wim de Körverstraat 35 | 5831 AN Boxmeer | Nederland |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35 | | | | | | | |
| 5831 AN Boxmeer | | | | | | | |
| Nederland | | | | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | --------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------- |
| 13.1.2009 | Novem | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein | | | | |
| 20.1.2009 | Fevaxyn Pentofel | Fort Dodge Laboratories Ireland Finisklin Industrial Estate — Sligo Ireland | Fort Dodge Laboratories Ireland | Finisklin Industrial Estate — Sligo |
| Fort Dodge Laboratories Ireland | | | | |
| Finisklin Industrial Estate — Sligo | | | | |
| Ireland | | | | |

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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