# C_2008056EN.01000501.xml

| 29.2.2008 | EN | Official Journal of the European Union | C 56/5 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 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 56/07)

—   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 |
| --------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | ---------------------- |
| 10.1.2008 | TESAVEL | Sitagliptin | Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road | Hoddesdon | Hertfordshire EN11 9BU |
| Merck Sharp & Dohme Ltd | | | | | | | |
| Hertford Road | | | | | | | |
| Hoddesdon | | | | | | | |
| Hertfordshire EN11 9BU | | | | | | | |
| United Kingdom | | | | | | | |
| 11.1.2008 | Abraxane | Paclitaxel | Abraxis BioScience Limited West Forest Gate Wellington Road Wokingham Berkshire RG40 2AQ United Kingdom | Abraxis BioScience Limited | West Forest Gate | Wellington Road | Wokingham |
| Abraxis BioScience Limited | | | | | | | |
| West Forest Gate | | | | | | | |
| Wellington Road | | | | | | | |
| Wokingham | | | | | | | |
| Berkshire RG40 2AQ | | | | | | | |
| United Kingdom | | | | | | | |
| 11.1.2008 | IVEMEND | Fosaprepitant dimeglumine | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom | Merck Sharp & Dohme Limited | Hertford Road | Hoddesdon | Hertfordshire EN11 9BU |
| Merck Sharp & Dohme Limited | | | | | | | |
| Hertford Road | | | | | | | |
| Hoddesdon | | | | | | | |
| Hertfordshire EN11 9BU | | | | | | | |
| United Kingdom | | | | | | | |
| 11.1.2008 | Avamys | Fluticasone furoate | Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd | Greenford | Middlesex UB6 0NN | United Kingdom |
| Glaxo Group Ltd | | | | | | | |
| Greenford | | | | | | | |
| Middlesex UB6 0NN | | | | | | | |
| United Kingdom | | | | | | | |

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

| 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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------------------ | --------------------------------------------- | -------------------- |
| 11.1.2008 | Natalizumab | Elan Pharma Ltd Norton Green Road Stevenage Herts SG1 2BA United Kingdom | Elan Pharma Ltd | Norton Green Road |
| Elan Pharma Ltd | | | | |
| Norton Green Road | | | | |
| Stevenage | | | | |
| Herts SG1 2BA | | | | |
| United Kingdom | | | | |

—   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 |
| ----------------------------------------------- | --------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------- |
| 8.1.2008 | Puregon | Organon N.V. Kloosterstraat 6 Postbus 20 5340 BH Oss Nederland | Organon N.V. | Kloosterstraat 6 |
| Organon N.V. | | | | |
| Kloosterstraat 6 | | | | |
| Postbus 20 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 8.1.2008 | DepoCyte | SkyePharma PLC 105 Piccadilly London W1J 7NJ United Kingdom Pacira Limited MG House Rumbolds Hill Midhurst West Sussex GU29 9BY United Kingdom | SkyePharma PLC | 105 Piccadilly |
| SkyePharma PLC | | | | |
| 105 Piccadilly | | | | |
| London W1J 7NJ | | | | |
| United Kingdom | | | | |
| Pacira Limited | | | | |
| MG House | | | | |
| Rumbolds Hill | | | | |
| Midhurst | | | | |
| West Sussex GU29 9BY | | | | |
| United Kingdom | | | | |
| 10.1.2008 | 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 | | | | |
| 10.1.2008 | Velcade | Janssen-Cilag International NV Turnhoutseweg, 30 B-2340 Beerse | Janssen-Cilag International NV | Turnhoutseweg, 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 | | | | |
| B-2340 Beerse | | | | |
| 10.1.2008 | 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 | | | | |
| 10.1.2008 | 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 | | | | |
| 10.1.2008 | Angiox | The Medicines Company UK Ltd Suite B Park House 11 Milton Park Abingdon Oxfordshire OX14 4RS United Kingdom | The Medicines Company UK Ltd | Suite B Park House |
| The Medicines Company UK Ltd | | | | |
| Suite B Park House | | | | |
| 11 Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire OX14 4RS | | | | |
| United Kingdom | | | | |
| 11.1.2008 | 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 | | | | |
| 11.1.2008 | Irbesartan HCT BMS | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UD8 1DH United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge UD8 1DH | | | | |
| United Kingdom | | | | |
| 14.1.2008 | Optaflu | Novartis Vaccines and Diagnostics GmbH & Co. KG Emil-von-Behring-Straße 76 D-35041 Marburg | Novartis Vaccines and Diagnostics GmbH & Co. KG | Emil-von-Behring-Straße 76 |
| Novartis Vaccines and Diagnostics GmbH & Co. KG | | | | |
| Emil-von-Behring-Straße 76 | | | | |
| D-35041 Marburg | | | | |
| 17.1.2008 | 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 | | | | |
| 17.1.2008 | 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 | | | | |
| 17.1.2008 | Neulasta | 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 | | | | |
| 17.1.2008 | Neupopeg | 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 | | | | |
| 17.1.2008 | Evoltra | Bioenvision Limited Bassett House 5 Southwell Park Road Camberley Surrey GU15 3PU United Kingdom | Bioenvision Limited | Bassett House |
| Bioenvision Limited | | | | |
| Bassett House | | | | |
| 5 Southwell Park Road | | | | |
| Camberley | | | | |
| Surrey GU15 3PU | | | | |
| United Kingdom | | | | |
| 17.1.2008 | Humira | Abbott laboratories Ltd Queenborough Kent ME11 5EL United Kingdom | Abbott laboratories Ltd | Queenborough |
| Abbott laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| United Kingdom | | | | |
| 17.1.2008 | Twinrix Adult | 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 | | | | |
| 18.1.2008 | Telzir | 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 | | | | |
| 18.1.2008 | Dynepo | 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 | | | | |
| 18.1.2008 | Zerene | Wyeth Research (UK) Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH United Kingdom Meda AB Pipers väg 2A S-170 09 Solna | Wyeth Research (UK) Limited | Huntercombe Lane South |
| Wyeth Research (UK) Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| United Kingdom | | | | |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| S-170 09 Solna | | | | |
| 18.1.2008 | Orgalutran | N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss Nederland | N.V. Organon | P.O. Box 20 |
| N.V. Organon | | | | |
| P.O. Box 20 | | | | |
| Kloosterstraat 6 | | | | |
| 5340 BH Oss | | | | |
| Nederland | | | | |
| 18.1.2008 | Mabthera | 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 | | | | |
| 18.1.2008 | 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 | | | | |
| 22.1.2008 | 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 | | | | |
| 22.1.2008 | Twinrix Paediatric | 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 | | | | |
| 25.1.2008 | 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 | | | | |
| 25.1.2008 | 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 | | | | |
| 25.1.2008 | Osseor | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |
| 25.1.2008 | Protelos | Les Laboratoires Servier 22, rue Garnier F-92200 Neuilly-sur-Seine | Les Laboratoires Servier | 22, rue Garnier |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier | | | | |
| F-92200 Neuilly-sur-Seine | | | | |
| 25.1.2008 | Exubera | 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 | | | | |
| 25.1.2008 | Galvus | 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 | | | | |
| 25.1.2008 | SUTENT | 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 | | | | |
| 25.1.2008 | Advagraf | Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp Nederland | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| D-81673 München | | | | |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| Nederland | | | | |
| 25.1.2008 | Onsenal | Pharmacia-Pfizer EEIG Ramsgate Road Sandwich CT13 9NJ United Kingdom Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom | Pharmacia-Pfizer EEIG | Ramsgate Road |
| Pharmacia-Pfizer EEIG | | | | |
| Ramsgate Road | | | | |
| Sandwich CT13 9NJ | | | | |
| United Kingdom | | | | |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 28.1.2008 | Irbesartan Hydrochlorothiazide 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 | | | | |
| 28.1.2008 | Macugen | 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 | | | | |
| 28.1.2008 | Vfend | 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 | | | | |
| 28.1.2008 | ViraferonPeg | 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 | | | | |
| 28.1.2008 | PegIntron | 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 | | | | |
| 28.1.2008 | IntronA | 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 | | | | |
| 28.1.2008 | Viraferon | 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 | | | | |
| 28.1.2008 | Agenerase | 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 | | | | |
| 28.1.2008 | 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 | | | | |
| 29.1.2008 | 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 | | | | |
| 31.1.2008 | Dynastat | 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 | | | | |
| 31.1.2008 | 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 | | | | |
| 31.1.2008 | 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 | | | | |
| 31.1.2008 | Naglazyme | BioMarin Europe Limited Axtell House 23-24 Warwick Street London W1B 5NQ United Kingdom | BioMarin Europe Limited | Axtell House |
| BioMarin Europe Limited | | | | |
| Axtell House | | | | |
| 23-24 Warwick Street | | | | |
| London W1B 5NQ | | | | |
| United Kingdom | | | | |

—   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 |
| ---------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------- | ---------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 10.1.2008 | Rheumocam | Meloxicam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea Co. Galway Ireland | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea | Co. Galway | Ireland |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | | | | |
| Loughrea | | | | | | | |
| Co. Galway | | | | | | | |
| Ireland | | | | | | | |
| 31.1.2008 | Nobilis Influenza H5N6 | Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test | 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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- |
| 3.1.2008 | ProMeris | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36 |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36 | | | | |
| 1381 CP Weesp | | | | |
| Nederland | | | | |
| 10.1.2008 | Nobilis OR Inac | 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 | | | | |
| 11.1.2008 | ProteqFlu Te | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 14.1.2008 | ProteqFlu | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 15.1.2008 | Dicural | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp Nederland | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36 |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36 | | | | |
| 1381 CP Weesp | | | | |
| Nederland | | | | |
| 17.1.2008 | Cerenia | 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 | | | | |
| 22.1.2008 | Purevax FelV | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | Purevax RCP FelV | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | Purevax RCCh | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | Purevax RCPCH FelV | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | Purevax RCPCh | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | ProteqFlu | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | ProteqFlu-Te | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 22.1.2008 | Purevax RC | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |
| 25.1.2008 | Purevax RCP | Merial 29, Avenue Tony Garnier F-69007 Lyon | Merial | 29, Avenue Tony Garnier |
| Merial | | | | |
| 29, Avenue Tony Garnier | | | | |
| F-69007 Lyon | | | | |

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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