# C_2014165EN.01000101.xml

| 29.5.2014 | EN | Official Journal of the European Union | C 165/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2014 to 30 April 2014

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

2014/C 165/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ---------------------------------------------------------------------- | -------------------------------- | ---------------------------------------- | --------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------- |
| 3.4.2014 | Rivastigmine 3M Health Care Ltd. | rivastigmine | 3M Health Care Limited 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom | 3M Health Care Limited | 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom | EU/1/14/911 | Transdermal patch |
| 3M Health Care Limited | | | | | | | |
| 1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom | | | | | | | |
| 4.4.2014 | Cholic Acid FGK | cholic acid | FGK Representative Service GmbH
Heimeranstraße 35, D-80339 München, Deutschland | EU/1/13/895 | Capsule, hard | A05AA03 | 8.4.2014 |
| 7.4.2014 | Para-aminosalicylic acid Lucane | Para-aminosalicylic acid | Lucane Pharma 172 rue de Charonne, 75011 Paris, France | Lucane Pharma | 172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | Gastro-resistant granules |
| Lucane Pharma | | | | | | | |
| 172 rue de Charonne, 75011 Paris, France | | | | | | | |
| 10.4.2014 | Pregabalin Pfizer | pregabalin | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | Capsule, hard |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | | | | |
| 23.4.2014 | Hemangiol | propranolol | PIERRE FABRE DERMATOLOGIE 45 place Abel Gance, F- 92100 Boulogne, France | PIERRE FABRE DERMATOLOGIE | 45 place Abel Gance, F- 92100 Boulogne, France | EU/1/14/919 | Oral solution |
| PIERRE FABRE DERMATOLOGIE | | | | | | | |
| 45 place Abel Gance, F- 92100 Boulogne, France | | | | | | | |
| 23.4.2014 | Ulunar Breezhaler | indacaterol/glycopyrronium bromide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/14/917 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | | | | |
| 23.4.2014 | Vokanamet | canagliflozin/metformin hydrochloride | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | Film-coated tablet |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | | | | |
| 28.4.2014 | BiResp Spiromax | budesonide/formoterol | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/921 | Inhalation powder |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | | | | |
| 28.4.2014 | Deltyba | delamanid | Otsuka Novel Products GmbH Erika-Mann-Straße 21, D-80636 München, Deutschland | Otsuka Novel Products GmbH | Erika-Mann-Straße 21, D-80636 München, Deutschland | EU/1/13/875 | Film-coated tablet |
| Otsuka Novel Products GmbH | | | | | | | |
| Erika-Mann-Straße 21, D-80636 München, Deutschland | | | | | | | |
| 28.4.2014 | DuoResp Spiromax | budesonide/formoterol | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/920 | Inhalation powder |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | | | | |
| 28.4.2014 | Incruse | umeclidinium bromide | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | Inhalation powder, pre-dispensed |
| Glaxo Group Ltd | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |
| 28.4.2014 | Vimizim | elosulfase alfa | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/14/914 | Concentrate and solvent for solution for infusion |
| BioMarin Europe Ltd | | | | | | | |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 3.4.2014 | Neuraceq | Piramal Imaging Limited Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom | Piramal Imaging Limited | Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom |
| Piramal Imaging Limited | | | | |
| Suite no. 10, Innovation Center, Unit 23, Science Park, Cambridge CB4 0EY, United Kingdom | | | | |
| 3.4.2014 | Xiapex | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 7.4.2014 | Exelon | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 10.4.2014 | Abilify | Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | Otsuka Pharmaceutical Europe Ltd. | Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd. | | | | |
| Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | | | | |
| 10.4.2014 | Clopidogrel Mylan | Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, F-69800 Saint Priest, France |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, F-69800 Saint Priest, France | | | | |
| 10.4.2014 | Lonquex | UAB ‘Sicor Biotech’ V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania | UAB ‘Sicor Biotech’ | V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania |
| UAB ‘Sicor Biotech’ | | | | |
| V. A. Graičiūno g. 8 LT-02241 Vilnius, Lithuania | | | | |
| 10.4.2014 | Pixuvri | CTI Life Sciences Ltd Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | CTI Life Sciences Ltd | Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom |
| CTI Life Sciences Ltd | | | | |
| Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | | | | |
| 10.4.2014 | Viramune | Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 11.4.2014 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | |
| 11.4.2014 | Mozobil | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 11.4.2014 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 15.4.2014 | Osseor | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 15.4.2014 | Protelos | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 23.4.2014 | Aloxi | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland | Helsinn Birex Pharmaceuticals Ltd | Damastown, Mulhuddart, Dublin 15, Ireland |
| Helsinn Birex Pharmaceuticals Ltd | | | | |
| Damastown, Mulhuddart, Dublin 15, Ireland | | | | |
| 23.4.2014 | Betmiga | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | |
| 23.4.2014 | Bretaris Genuair | Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, E-08022 Barcelona, España |
| Almirall, S.A. | | | | |
| Ronda General Mitre, 151, E-08022 Barcelona, España | | | | |
| 23.4.2014 | CANCIDAS | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.4.2014 | Eklira Genuair | Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, E-08022 Barcelona, España |
| Almirall, S.A. | | | | |
| Ronda General Mitre, 151, E-08022 Barcelona, España | | | | |
| 23.4.2014 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige | | | | |
| 23.4.2014 | Ferriprox | Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwinweg 20, NL- 2333 CR Leiden, Nederland |
| Apotex Europe B.V. | | | | |
| Darwinweg 20, NL- 2333 CR Leiden, Nederland | | | | |
| 23.4.2014 | Instanyl | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 23.4.2014 | Integrilin | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 23.4.2014 | Iressa | AstraZeneca AB SE-151 85 Södertälje, Sverige | AstraZeneca AB | SE-151 85 Södertälje, Sverige |
| AstraZeneca AB | | | | |
| SE-151 85 Södertälje, Sverige | | | | |
| 23.4.2014 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92165 Antony CEDEX, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92165 Antony CEDEX, France | | | | |
| 23.4.2014 | Nimenrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, 1330 Rixensart, Belgique | | | | |
| 23.4.2014 | Noxafil | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.4.2014 | Onglyza | Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 23.4.2014 | Pegasys | 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, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.4.2014 | Qutenza | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | |
| 23.4.2014 | Rivastigmine HEXAL | Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | Hexal AG | Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
| Hexal AG | | | | |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland | | | | |
| 23.4.2014 | RoActemra | 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, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.4.2014 | Ryzodeg | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 23.4.2014 | Siklos | Addmedica 101 rue Saint Lazare, F-75009 Paris, France | Addmedica | 101 rue Saint Lazare, F-75009 Paris, France |
| Addmedica | | | | |
| 101 rue Saint Lazare, F-75009 Paris, France | | | | |
| 23.4.2014 | Stocrin | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.4.2014 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 23.4.2014 | Vedrop | Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | Orphan Europe S.A.R.L. | Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
| Orphan Europe S.A.R.L. | | | | |
| Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | | | | |
| 23.4.2014 | Vfend | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 23.4.2014 | Volibris | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 28.4.2014 | alli | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 28.4.2014 | Avamys | Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 28.4.2014 | Exjade | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 28.4.2014 | Glybera | uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | uniQure biopharma B.V. | Meibergdreef 61, NL-1105 BA Amsterdam, Nederland |
| uniQure biopharma B.V. | | | | |
| Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | | | | |
| 28.4.2014 | Orencia | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 28.4.2014 | Pegasys | 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, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 28.4.2014 | Rebetol | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 28.4.2014 | Ribavirin Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 28.4.2014 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 28.4.2014 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 28.4.2014 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | | | | |
| 28.4.2014 | Tepadina | ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia | ADIENNE S.r.l. | Via Galileo Galilei 19, 20867 Caponago (MB), Italia |
| ADIENNE S.r.l. | | | | |
| Via Galileo Galilei 19, 20867 Caponago (MB), Italia | | | | |
| 28.4.2014 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council( 2 )): 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 |
| -------------------------------------------- | ----------------------------- | ---------------------------------------- | --------------------------------------------------- | --------------------------------------------- | -------------------------------------------- | ----------------------------------------------- | --------------------------------------------------- |
| 11.4.2014 | Parvoduk | Live attenuated Muscovy duck parvovirus | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/14/162 | Suspension and diluent for suspension for injection |
| Merial | | | | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 7.4.2014 | Aftovaxpur Doe | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 10.4.2014 | Equilis StrepE | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |
| 10.4.2014 | Improvac | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 11.4.2014 | BTVPUR AlSap 2-4 | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |

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 |
| UK — LONDON E14 4H |

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( 1 )  OJ L 136, 30.4.04, p. 1.

( 2 )  OJ L 136, 30.4.04, p. 1.

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