# C_2015211EN.01000101.xml

| 26.6.2015 | EN | Official Journal of the European Union | C 211/1 |
| --- | --- | --- | --- |

26.6.2015

EN

Official Journal of the European Union

C 211/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2015 to 31 May 2015

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

1

(2015/C 211/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Issuing of a marketing authorization

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2015 | Zykadia | ceritinib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | Capsule, hard | L01XE | 8.5.2015 |
| 27.5.2015 | Akynzeo | netupitant/palonosetron | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | Capsule, hard | A04AA55 | 29.5.2015 |
| 27.5.2015 | Jinarc | tolvaptan | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | Tablet | Pending | 29.5.2015 |
| 27.5.2015 | Synjardy | empagliflozin/metformin | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | Film-coated tablet | A10BD20 | 29.5.2015 |
| 27.5.2015 | Voriconazole Hospira | voriconazole | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | Powder for solution for infusion | J02AC03 | 29.5.2015 |
| 28.5.2015 | Lenvima | lenvatinib | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/15/1002 | Capsule, hard | L01XE29 | 1.6.2015 |

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

6.5.2015

Zykadia

ceritinib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

Capsule, hard

L01XE

8.5.2015

27.5.2015

Akynzeo

netupitant/palonosetron

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

Capsule, hard

A04AA55

29.5.2015

27.5.2015

Jinarc

tolvaptan

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

Tablet

Pending

29.5.2015

27.5.2015

Synjardy

empagliflozin/metformin

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/15/1003

Film-coated tablet

A10BD20

29.5.2015

27.5.2015

Voriconazole Hospira

voriconazole

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/15/1004

Powder for solution for infusion

J02AC03

29.5.2015

28.5.2015

Lenvima

lenvatinib

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/15/1002

Capsule, hard

L01XE29

1.6.2015

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 5.5.2015 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 7.5.2015 |
| 5.5.2015 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 7.5.2015 |
| 5.5.2015 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 7.5.2015 |
| 5.5.2015 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 7.5.2015 |
| 5.5.2015 | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 8.5.2015 |
| 5.5.2015 | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 7.5.2015 |
| 5.5.2015 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 7.5.2015 |
| 5.5.2015 | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 7.5.2015 |
| 5.5.2015 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 7.5.2015 |
| 5.5.2015 | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 8.5.2015 |
| 5.5.2015 | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 8.5.2015 |
| 5.5.2015 | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 7.5.2015 |
| 5.5.2015 | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 8.5.2015 |
| 5.5.2015 | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 7.5.2015 |
| 5.5.2015 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 7.5.2015 |
| 5.5.2015 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 7.5.2015 |
| 5.5.2015 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 7.5.2015 |
| 5.5.2015 | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 7.5.2015 |
| 5.5.2015 | Zypadhera | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/479 | 7.5.2015 |
| 6.5.2015 | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 8.5.2015 |
| 6.5.2015 | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 8.5.2015 |
| 6.5.2015 | Celvapan | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/08/506 | 8.5.2015 |
| 6.5.2015 | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 8.5.2015 |
| 6.5.2015 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 8.5.2015 |
| 6.5.2015 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 8.5.2015 |
| 6.5.2015 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 8.5.2015 |
| 6.5.2015 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 8.5.2015 |
| 13.5.2015 | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 19.5.2015 |
| 13.5.2015 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.5.2015 |
| 13.5.2015 | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 19.5.2015 |
| 13.5.2015 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.5.2015 |
| 13.5.2015 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 19.5.2015 |
| 13.5.2015 | Luminity | Lantheus MI UK Limited
  Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | EU/1/06/361 | 19.5.2015 |
| 13.5.2015 | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 19.5.2015 |
| 13.5.2015 | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165 | 19.5.2015 |
| 13.5.2015 | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 19.5.2015 |
| 13.5.2015 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.5.2015 |
| 13.5.2015 | Vyndaqel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/11/717 | 19.5.2015 |
| 27.5.2015 | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 29.5.2015 |
| 27.5.2015 | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 29.5.2015 |
| 27.5.2015 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 29.5.2015 |
| 27.5.2015 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | EU/1/09/555 | 29.5.2015 |
| 27.5.2015 | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 29.5.2015 |
| 27.5.2015 | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 29.5.2015 |
| 27.5.2015 | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 29.5.2015 |
| 27.5.2015 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/12/750 | 29.5.2015 |
| 27.5.2015 | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 29.5.2015 |
| 27.5.2015 | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 29.5.2015 |
| 27.5.2015 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 29.5.2015 |
| 27.5.2015 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 29.5.2015 |
| 27.5.2015 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.5.2015 |
| 27.5.2015 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 29.5.2015 |
| 27.5.2015 | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 29.5.2015 |
| 27.5.2015 | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.5.2015 |
| 27.5.2015 | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 29.5.2015 |
| 27.5.2015 | Nivestim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631 | 29.5.2015 |
| 27.5.2015 | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 29.5.2015 |
| 27.5.2015 | Raloxifene Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/627 | 29.6.2015 |
| 27.5.2015 | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 29.5.2015 |
| 27.5.2015 | Resolor | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/09/581 | 29.5.2015 |
| 27.5.2015 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | 29.5.2015 |
| 27.5.2015 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 29.5.2015 |
| 27.5.2015 | Sonata | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/99/102 | 29.5.2015 |
| 27.5.2015 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 29.5.2015 |
| 27.5.2015 | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 29.5.2015 |
| 27.5.2015 | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 29.5.2015 |
| 27.5.2015 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 29.5.2015 |
| 27.5.2015 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 29.5.2015 |
| 27.5.2015 | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 29.5.2015 |
| 27.5.2015 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 29.5.2015 |
| 27.5.2015 | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 29.5.2015 |
| 27.5.2015 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 29.5.2015 |
| 27.5.2015 | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 29.5.2015 |
| 27.5.2015 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 29.5.2015 |
| 28.5.2015 | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 1.6.2015 |
| 28.5.2015 | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 1.6.2015 |
| 28.5.2015 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 1.6.2015 |
| 28.5.2015 | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/07/395 | 1.6.2015 |
| 28.5.2015 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 1.6.2015 |
| 28.5.2015 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 1.6.2015 |
| 28.5.2015 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 1.6.2015 |
| 28.5.2015 | Topotecan Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/633 | 1.6.2015 |
| 28.5.2015 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 1.6.2015 |

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

5.5.2015

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

7.5.2015

5.5.2015

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

7.5.2015

5.5.2015

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

7.5.2015

5.5.2015

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

7.5.2015

5.5.2015

Erivedge

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/848

8.5.2015

5.5.2015

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

7.5.2015

5.5.2015

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

7.5.2015

5.5.2015

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

7.5.2015

5.5.2015

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

7.5.2015

5.5.2015

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

8.5.2015

5.5.2015

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

8.5.2015

5.5.2015

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/10/640

7.5.2015

5.5.2015

Tamiflu

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222

8.5.2015

5.5.2015

Telzir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/282

7.5.2015

5.5.2015

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

7.5.2015

5.5.2015

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/13/857

7.5.2015

5.5.2015

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

7.5.2015

5.5.2015

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

7.5.2015

5.5.2015

Zypadhera

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/479

7.5.2015

6.5.2015

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

8.5.2015

6.5.2015

Celsentri

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/07/418

8.5.2015

6.5.2015

Celvapan

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506

8.5.2015

6.5.2015

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

8.5.2015

6.5.2015

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

8.5.2015

6.5.2015

Optaflu

Novartis Influenza Vaccines Marburg GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

8.5.2015

6.5.2015

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

8.5.2015

6.5.2015

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

8.5.2015

13.5.2015

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

19.5.2015

13.5.2015

Efficib

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457

19.5.2015

13.5.2015

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

19.5.2015

13.5.2015

Janumet

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455

19.5.2015

13.5.2015

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/10/654

19.5.2015

13.5.2015

Luminity

Lantheus MI UK Limited

Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom

EU/1/06/361

19.5.2015

13.5.2015

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

19.5.2015

13.5.2015

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165

19.5.2015

13.5.2015

Trizivir

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/00/156

19.5.2015

13.5.2015

Velmetia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456

19.5.2015

13.5.2015

Vyndaqel

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/11/717

19.5.2015

27.5.2015

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/658

29.5.2015

27.5.2015

Ariclaim

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/283

29.5.2015

27.5.2015

Brinavess

Cardiome UK Limited

Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/10/645

29.5.2015

27.5.2015

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

EU/1/09/555

29.5.2015

27.5.2015

Cometriq

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

29.5.2015

27.5.2015

Cymbalta

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/296

29.5.2015

27.5.2015

Erivedge

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/848

29.5.2015

27.5.2015

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/12/750

29.5.2015

27.5.2015

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

29.5.2015

27.5.2015

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

29.5.2015

27.5.2015

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

29.5.2015

27.5.2015

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

29.5.2015

27.5.2015

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

29.5.2015

27.5.2015

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

29.5.2015

27.5.2015

Levetiracetam Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/11/712

29.5.2015

27.5.2015

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

EU/1/10/647

29.5.2015

27.5.2015

Nexium Control

Pfizer Consumer Healthcare Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/13/860

29.5.2015

27.5.2015

Nivestim

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631

29.5.2015

27.5.2015

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

29.5.2015

27.5.2015

Raloxifene Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/627

29.6.2015

27.5.2015

Relistor

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/08/463

29.5.2015

27.5.2015

Resolor

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

29.5.2015

27.5.2015

Selincro

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/12/815

29.5.2015

27.5.2015

Silgard

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358

29.5.2015

27.5.2015

Sonata

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/99/102

29.5.2015

27.5.2015

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

29.5.2015

27.5.2015

Targretin

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/01/178

29.5.2015

27.5.2015

Temodal

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/98/096

29.5.2015

27.5.2015

Temozolomide Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/10/615

29.5.2015

27.5.2015

Thalidomide Celgene

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

29.5.2015

27.5.2015

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

29.5.2015

27.5.2015

Volibris

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/08/451

29.5.2015

27.5.2015

Xeristar

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/297

29.5.2015

27.5.2015

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

29.5.2015

27.5.2015

Yentreve

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/04/280

29.5.2015

27.5.2015

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

29.5.2015

28.5.2015

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

1.6.2015

28.5.2015

alli

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/07/401

1.6.2015

28.5.2015

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/11/733

1.6.2015

28.5.2015

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

1.6.2015

28.5.2015

Januvia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383

1.6.2015

28.5.2015

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

1.6.2015

28.5.2015

Ristaben

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621

1.6.2015

28.5.2015

Topotecan Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633

1.6.2015

28.5.2015

Tygacil

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/336

1.6.2015

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorization

| 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 |
| --- | --- | --- | --- | --- |
| 5.5.2015 | Clopidogrel DURA | Mylan dura GmbH
  Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560 | 7.5.2015 |
| 6.5.2015 | Provenge | Dendreon UK Limited
  41 Chalton Street, London NW1 1JD, United Kingdom | EU/1/13/867 | 8.5.2015 |

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

5.5.2015

Clopidogrel DURA

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560

7.5.2015

6.5.2015

Provenge

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

EU/1/13/867

8.5.2015

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 5.5.2015 | MS-H vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 7.5.2015 |
| 5.5.2015 | Purevax RCP | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/052 | 7.5.2015 |
| 13.5.2015 | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 19.5.2015 |
| 13.5.2015 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 19.5.2015 |
| 27.5.2015 | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2015 |
| 27.5.2015 | Purevax FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/00/019 | 29.5.2015 |
| 27.5.2015 | Purevax RCPCh | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/050 | 29.5.2015 |
| 27.5.2015 | Suprelorin | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France | EU/2/07/072 | 29.5.2015 |

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

5.5.2015

MS-H vaccine

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

7.5.2015

5.5.2015

Purevax RCP

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/052

7.5.2015

13.5.2015

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/98/006

19.5.2015

13.5.2015

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

19.5.2015

27.5.2015

Meloxivet

Eli Lilly and Company Limited

Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/07/077

29.5.2015

27.5.2015

Purevax FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/00/019

29.5.2015

27.5.2015

Purevax RCPCh

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/050

29.5.2015

27.5.2015

Suprelorin

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France

EU/2/07/072

29.5.2015

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

(1)  OJ L 136, 30.4.2004, p. 1.

1

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