# C_2016076EN.01000101.xml

| 26.2.2016 | EN | Official Journal of the European Union | C 76/1 |
| --- | --- | --- | --- |

26.2.2016

EN

Official Journal of the European Union

C 76/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2016 to 31 January 2016

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

1

(2016/C 076/01)

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

Issuing of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.1.2016 | Eptifibatide Accord | eptifibatide | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1065 | Solution for infusion
  Solution for injection | B01AC16 | 13.1.2016 |
| 14.1.2016 | Benepali | etanercept | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | Solution for injection | L04AB01 | 18.1.2016 |
| 14.1.2016 | Briviact | brivaracetam | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | Film-coated tablet
  Oral solution
  Solution for injection or infusion | N03AX23 | 18.1.2016 |
| 14.1.2016 | Episalvan | birch bark extract | Birken AG
  Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland | EU/1/15/1069 | Gel | Pending | 18.1.2016 |
| 14.1.2016 | Lopinavir/Ritonavir Mylan | lopinavir/ritonavir | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1067 | Film-coated tablet | J05AR10 | 18.1.2016 |
| 14.1.2016 | Oncaspar | pegaspargase | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | EU/1/15/1070 | Powder and solvent for solution for injection/infusion | L01XX24 | 18.1.2016 |
| 14.1.2016 | Spectrila | asparaginase | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/15/1072 | Powder for concentrate for solution for infusion | L01XX02 | 18.1.2016 |
| 18.1.2016 | Pemetrexed Accord | pemetrexed | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | Powder for concentrate for solution for infusion | L01BA04 | 20.1.2016 |
| 18.1.2016 | Pemetrexed Actavis | pemetrexed | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/15/1063 | Concentrate for solution for infusion | L01BA04 | 21.1.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

11.1.2016

Eptifibatide Accord

eptifibatide

Accord Healthcare Limited

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

EU/1/15/1065

Solution for infusion

Solution for injection

B01AC16

13.1.2016

14.1.2016

Benepali

etanercept

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

Solution for injection

L04AB01

18.1.2016

14.1.2016

Briviact

brivaracetam

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/15/1073

Film-coated tablet

Oral solution

Solution for injection or infusion

N03AX23

18.1.2016

14.1.2016

Episalvan

birch bark extract

Birken AG

Streiflingsweg 11, D-75223 Niefern-Öschelbronn, Deutschland

EU/1/15/1069

Gel

Pending

18.1.2016

14.1.2016

Lopinavir/Ritonavir Mylan

lopinavir/ritonavir

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/15/1067

Film-coated tablet

J05AR10

18.1.2016

14.1.2016

Oncaspar

pegaspargase

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

EU/1/15/1070

Powder and solvent for solution for injection/infusion

L01XX24

18.1.2016

14.1.2016

Spectrila

asparaginase

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/15/1072

Powder for concentrate for solution for infusion

L01XX02

18.1.2016

18.1.2016

Pemetrexed Accord

pemetrexed

Accord Healthcare Limited

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

EU/1/15/1071

Powder for concentrate for solution for infusion

L01BA04

20.1.2016

18.1.2016

Pemetrexed Actavis

pemetrexed

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/15/1063

Concentrate for solution for infusion

L01BA04

21.1.2016

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2016 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 11.1.2016 |
| 7.1.2016 | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 11.1.2016 |
| 7.1.2016 | Sildenafil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/584 | 11.1.2016 |
| 7.1.2016 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | 11.1.2016 |
| 11.1.2016 | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 13.1.2016 |
| 11.1.2016 | Latuda | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | 13.1.2016 |
| 11.1.2016 | Sivextro | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/991 | 13.1.2016 |
| 11.1.2016 | Yellox | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/11/692 | 13.1.2016 |
| 11.1.2016 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 13.1.2016 |
| 12.1.2016 | Atriance | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/403 | 14.1.2016 |
| 12.1.2016 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 14.1.2016 |
| 12.1.2016 | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 14.1.2016 |
| 12.1.2016 | Gardasil 9 | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 14.1.2016 |
| 12.1.2016 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 14.1.2016 |
| 14.1.2016 | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom. | EU/1/12/760 | 18.1.2016 |
| 14.1.2016 | Caprelsa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/749 | 18.1.2016 |
| 14.1.2016 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 18.1.2016 |
| 14.1.2016 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 18.1.2016 |
| 14.1.2016 | Glivec | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/198 | 18.1.2016 |
| 14.1.2016 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 19.1.2016 |
| 14.1.2016 | Lumigan | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/02/205 | 18.1.2016 |
| 14.1.2016 | Pravafenix | LABORATOIRES SMB SA
  26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België | EU/1/11/679 | 18.1.2016 |
| 14.1.2016 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/05/330 | 18.1.2016 |
| 14.1.2016 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 18.1.2016 |
| 14.1.2016 | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 18.1.2016 |
| 14.1.2016 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274 | 18.1.2016 |
| 14.1.2016 | Xeloda | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/163 | 18.1.2016 |
| 18.1.2016 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 20.1.2016 |
| 18.1.2016 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 20.1.2016 |
| 18.1.2016 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 20.1.2016 |
| 22.1.2016 | Clopidogrel Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/561 | 26.1.2016 |
| 22.1.2016 | Kadcyla | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/885 | 26.1.2016 |
| 22.1.2016 | Levitra | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/248 | 26.1.2016 |
| 22.1.2016 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706 | 26.1.2016 |
| 22.1.2016 | Neupro | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/05/331 | 26.1.2016 |
| 22.1.2016 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 26.1.2016 |
| 22.1.2016 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 26.1.2016 |
| 22.1.2016 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 26.1.2016 |
| 22.1.2016 | Topotecan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/09/536 | 27.1.2016 |
| 22.1.2016 | Ulunar Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/917 | 26.1.2016 |
| 22.1.2016 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 26.1.2016 |
| 22.1.2016 | Vivanza | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/249 | 26.1.2016 |
| 25.1.2016 | Corlentor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/05/317 | 27.1.2016 |
| 25.1.2016 | Cyramza | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/957 | 27.1.2016 |
| 25.1.2016 | Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/708 | 27.1.2016 |
| 25.1.2016 | Exviera | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/983 | 27.1.2016 |
| 25.1.2016 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 27.1.2016 |
| 25.1.2016 | NovoRapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119 | 27.1.2016 |
| 25.1.2016 | Procoralan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/05/316 | 27.1.2016 |
| 25.1.2016 | SANCUSO | ProStrakan Limited
  Galabank Business Park, Galashiels TD1 1QH, United Kingdom | EU/1/12/766 | 27.1.2016 |
| 25.1.2016 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/09/595 | 27.1.2016 |
| 25.1.2016 | Sildenafil ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603 | 28.1.2016 |
| 25.1.2016 | Stalevo | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/03/260 | 27.1.2016 |
| 25.1.2016 | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 27.1.2016 |
| 25.1.2016 | Travatan | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/01/199 | 27.1.2016 |
| 25.1.2016 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274 | 27.1.2016 |
| 25.1.2016 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 27.1.2016 |
| 28.1.2016 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 1.2.2016 |
| 28.1.2016 | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 D-Miesbach, Deutschland | EU/1/09/532 | 1.2.2016 |
| 28.1.2016 | Comtess | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/98/082 | 1.2.2016 |
| 28.1.2016 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 1.2.2016 |
| 28.1.2016 | Defitelio | Gentium S.p.A.
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 1.2.2016 |
| 28.1.2016 | Nonafact | Sanquin Plasma Products B.V.
  Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland | EU/1/01/186 | 1.2.2016 |
| 28.1.2016 | Relistor | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/08/463 | 1.2.2016 |
| 28.1.2016 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 1.2.2016 |
| 28.1.2016 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 1.2.2016 |
| 28.1.2016 | Ultibro Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/862 | 1.2.2016 |
| 28.1.2016 | Voriconazole Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | 1.2.2016 |
| 28.1.2016 | Xoterna Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/863 | 1.2.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2016

Bosulif

Pfizer Limited

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

EU/1/13/818

11.1.2016

7.1.2016

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

11.1.2016

7.1.2016

Sildenafil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/584

11.1.2016

7.1.2016

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

11.1.2016

11.1.2016

Cometriq

TMC Pharma Services Ltd

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

EU/1/13/890

13.1.2016

11.1.2016

Latuda

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

13.1.2016

11.1.2016

Sivextro

Merck Sharp & Dohme Limited

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

EU/1/15/991

13.1.2016

11.1.2016

Yellox

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/11/692

13.1.2016

11.1.2016

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

13.1.2016

12.1.2016

Atriance

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/403

14.1.2016

12.1.2016

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

14.1.2016

12.1.2016

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

14.1.2016

12.1.2016

Gardasil 9

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

14.1.2016

12.1.2016

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

14.1.2016

14.1.2016

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom.

EU/1/12/760

18.1.2016

14.1.2016

Caprelsa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/749

18.1.2016

14.1.2016

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

18.1.2016

14.1.2016

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

18.1.2016

14.1.2016

Glivec

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/198

18.1.2016

14.1.2016

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

19.1.2016

14.1.2016

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

18.1.2016

14.1.2016

Pravafenix

LABORATOIRES SMB SA

26-28 rue de la Pastorale/26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België

EU/1/11/679

18.1.2016

14.1.2016

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/05/330

18.1.2016

14.1.2016

Torisel

Pfizer Limited

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

EU/1/07/424

18.1.2016

14.1.2016

Trobalt

Glaxo Group Ltd

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

EU/1/11/681

18.1.2016

14.1.2016

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

18.1.2016

14.1.2016

Xeloda

Roche Registration Limited

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

EU/1/00/163

18.1.2016

18.1.2016

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

20.1.2016

18.1.2016

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

20.1.2016

18.1.2016

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

20.1.2016

22.1.2016

Clopidogrel Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/561

26.1.2016

22.1.2016

Kadcyla

Roche Registration Limited

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

EU/1/13/885

26.1.2016

22.1.2016

Levitra

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/248

26.1.2016

22.1.2016

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

26.1.2016

22.1.2016

Neupro

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

26.1.2016

22.1.2016

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

26.1.2016

22.1.2016

Ofev

Boehringer Ingelheim International GmbH

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

EU/1/14/979

26.1.2016

22.1.2016

Optaflu

Novartis Influenza Vaccines Marburg GmbH

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

EU/1/07/394

26.1.2016

22.1.2016

Topotecan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/09/536

27.1.2016

22.1.2016

Ulunar Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/917

26.1.2016

22.1.2016

Viagra

Pfizer Limited

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

EU/1/98/077

26.1.2016

22.1.2016

Vivanza

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/249

26.1.2016

25.1.2016

Corlentor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/05/317

27.1.2016

25.1.2016

Cyramza

Eli Lilly Nederland B.V.

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

EU/1/14/957

27.1.2016

25.1.2016

Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708

27.1.2016

25.1.2016

Exviera

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/983

27.1.2016

25.1.2016

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

27.1.2016

25.1.2016

NovoRapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119

27.1.2016

25.1.2016

Procoralan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/05/316

27.1.2016

25.1.2016

SANCUSO

ProStrakan Limited

Galabank Business Park, Galashiels TD1 1QH, United Kingdom

EU/1/12/766

27.1.2016

25.1.2016

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/09/595

27.1.2016

25.1.2016

Sildenafil ratiopharm

ratiopharm GmbH

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

EU/1/09/603

28.1.2016

25.1.2016

Stalevo

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/03/260

27.1.2016

25.1.2016

Tarceva

Roche Registration Limited

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

EU/1/05/311

27.1.2016

25.1.2016

Travatan

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/01/199

27.1.2016

25.1.2016

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274

27.1.2016

25.1.2016

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

27.1.2016

28.1.2016

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

1.2.2016

28.1.2016

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 D-Miesbach, Deutschland

EU/1/09/532

1.2.2016

28.1.2016

Comtess

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/98/082

1.2.2016

28.1.2016

Daklinza

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

1.2.2016

28.1.2016

Defitelio

Gentium S.p.A.

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

EU/1/13/878

1.2.2016

28.1.2016

Nonafact

Sanquin Plasma Products B.V.

Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland

EU/1/01/186

1.2.2016

28.1.2016

Relistor

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/08/463

1.2.2016

28.1.2016

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

1.2.2016

28.1.2016

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

1.2.2016

28.1.2016

Ultibro Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/862

1.2.2016

28.1.2016

Voriconazole Hospira

Hospira UK Limited

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

EU/1/15/1004

1.2.2016

28.1.2016

Xoterna Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/863

1.2.2016

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.1.2016 | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/118 | 11.1.2016 |
| 7.1.2016 | CaniLeish | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France | EU/2/11/121 | 11.1.2016 |
| 7.1.2016 | Cimalgex | Vétoquinol SA
  Magny-Vernois, F-70200 Lure, France | EU/2/10/119 | 11.1.2016 |
| 7.1.2016 | Comfortis | Eli Lilly and Company Ltd, Elanco Animal Health
  Lilly House Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/10/115 | 11.1.2016 |
| 7.1.2016 | Melosus | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, D-31303 Burgdorf, Deutschland | EU/2/10/116 | 11.1.2016 |
| 7.1.2016 | Neocolipor | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/98/008 | 11.1.2016 |
| 7.1.2016 | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 11.1.2016 |
| 7.1.2016 | Zulvac 1 + 8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 11.1.2016 |
| 14.1.2016 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 18.1.2016 |
| 22.1.2016 | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170 Amer (Girona), España | EU/2/14/167 | 26.1.2016 |
| 22.1.2016 | Purevax RCPCh FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/047 | 26.1.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.1.2016

Activyl

Intervet International B.V.

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

EU/2/10/118

11.1.2016

7.1.2016

CaniLeish

VIRBAC S.A.

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

EU/2/11/121

11.1.2016

7.1.2016

Cimalgex

Vétoquinol SA

Magny-Vernois, F-70200 Lure, France

EU/2/10/119

11.1.2016

7.1.2016

Comfortis

Eli Lilly and Company Ltd, Elanco Animal Health

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

EU/2/10/115

11.1.2016

7.1.2016

Melosus

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, D-31303 Burgdorf, Deutschland

EU/2/10/116

11.1.2016

7.1.2016

Neocolipor

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/98/008

11.1.2016

7.1.2016

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

11.1.2016

7.1.2016

Zulvac 1 + 8 Ovis

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/120

11.1.2016

14.1.2016

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

18.1.2016

22.1.2016

ERYSENG PARVO

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170 Amer (Girona), España

EU/2/14/167

26.1.2016

22.1.2016

Purevax RCPCh FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/047

26.1.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

1

---