# Official Journal C 116/1 Ap

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 116 |
| | |
| English edition | Information and Notices | Volume 591 April 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 116

English edition

Information and Notices

Volume 591 April 2016

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 116/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 116/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 1.4.2016 | EN | Official Journal of the European Union | C 116/1 |
| --- | --- | --- | --- |

1.4.2016

EN

Official Journal of the European Union

C 116/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016

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

(2016/C 116/01)

—   Issuing of a marketing authorisation (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.2.2016 | TAGRISSO | osimertinib | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1086 | Film-coated tablet | L01XE35 | 4.2.2016 |
| 11.2.2016 | Caspofungin Accord | caspofungin | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1081 | Powder for concentrate for solution for infusion | J02AX04 | 15.2.2016 |
| 15.2.2016 | Portrazza | necitumumab | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/15/1084 | Concentrate for solution for infusion | L01XC22 | 18.2.2016 |
| 15.2.2016 | Vaxelis | Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1079 | Suspension for injection | J07CA09 | 17.2.2016 |
| 18.2.2016 | Feraccru | ferric maltol | Iron Therapeutics (UK) Ltd
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | Capsule, hard | B03AB10 | 22.2.2016 |
| 18.2.2016 | Iblias | octocog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1077 | Powder and solvent for solution for injection | B02BD02 | 22.2.2016 |
| 18.2.2016 | Kovaltry | octocog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1076 | Powder and solvent for solution for injection | B02BD02 | 22.2.2016 |
| 18.2.2016 | Zurampic | lesinurad | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1080 | Film-coated tablet | M04AB05 | 22.2.2016 |

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

2.2.2016

TAGRISSO

osimertinib

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1086

Film-coated tablet

L01XE35

4.2.2016

11.2.2016

Caspofungin Accord

caspofungin

Accord Healthcare Limited

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

EU/1/15/1081

Powder for concentrate for solution for infusion

J02AX04

15.2.2016

15.2.2016

Portrazza

necitumumab

Eli Lilly Nederland B.V.

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

EU/1/15/1084

Concentrate for solution for infusion

L01XC22

18.2.2016

15.2.2016

Vaxelis

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1079

Suspension for injection

J07CA09

17.2.2016

18.2.2016

Feraccru

ferric maltol

Iron Therapeutics (UK) Ltd

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

Capsule, hard

B03AB10

22.2.2016

18.2.2016

Iblias

octocog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1077

Powder and solvent for solution for injection

B02BD02

22.2.2016

18.2.2016

Kovaltry

octocog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1076

Powder and solvent for solution for injection

B02BD02

22.2.2016

18.2.2016

Zurampic

lesinurad

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1080

Film-coated tablet

M04AB05

22.2.2016

—   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 |
| --- | --- | --- | --- | --- |
| 8.2.2016 | Hepsera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/251 | 10.2.2016 |
| 8.2.2016 | Irbesartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/576 | 10.2.2016 |
| 8.2.2016 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/070 | 10.2.2016 |
| 8.2.2016 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 10.2.2016 |
| 8.2.2016 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/069 | 10.2.2016 |
| 8.2.2016 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 10.2.2016 |
| 11.2.2016 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/952 | 15.2.2016 |
| 11.2.2016 | Simbrinza | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | 15.2.2016 |
| 11.2.2016 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 15.2.2016 |
| 11.2.2016 | Truvada | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/04/305 | 15.2.2016 |
| 11.2.2016 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/883 | 15.2.2016 |
| 11.2.2016 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 15.2.2016 |
| 11.2.2016 | Zoledronic acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/771 | 15.2.2016 |
| 11.2.2016 | Zostavax | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 15.2.2016 |
| 11.2.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 15.2.2016 |
| 15.2.2016 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom | EU/1/14/913 | 17.2.2016 |
| 15.2.2016 | Rivastigmine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/693 | 17.2.2016 |
| 18.2.2016 | Aldara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/98/080 | 22.2.2016 |
| 18.2.2016 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/700 | 22.2.2016 |
| 18.2.2016 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 22.2.2016 |
| 18.2.2016 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 22.2.2016 |
| 18.2.2016 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 22.2.2016 |
| 18.2.2016 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/11/687 | 22.2.2016 |
| 18.2.2016 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 22.2.2016 |
| 18.2.2016 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 22.2.2016 |
| 18.2.2016 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 22.2.2016 |
| 18.2.2016 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 22.2.2016 |
| 18.2.2016 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 22.2.2016 |
| 18.2.2016 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 22.2.2016 |
| 18.2.2016 | TOBI Podhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/652 | 22.2.2016 |
| 18.2.2016 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 22.2.2016 |
| 18.2.2016 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 22.2.2016 |
| 22.2.2016 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 24.2.2016 |
| 22.2.2016 | Constella | Allergan Pharmaceuticals International Ltd
  Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland | EU/1/12/801 | 24.2.2016 |
| 22.2.2016 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 24.2.2016 |
| 22.2.2016 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/00/170 | 24.2.2016 |
| 22.2.2016 | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 24.2.2016 |
| 22.2.2016 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | 24.2.2016 |
| 22.2.2016 | Scintimun | CIS bio international
  Boîte postale 32, F-91192 Gif-sur-Yvette, France | EU/1/09/602 | 24.2.2016 |
| 22.2.2016 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 24.2.2016 |
| 22.2.2016 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 24.2.2016 |
| 22.2.2016 | Zoledronic acid Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/12/786 | 24.2.2016 |
| 24.2.2016 | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/538 | 26.2.2016 |
| 24.2.2016 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 26.2.2016 |
| 24.2.2016 | Firdapse | BioMarin Europe Ltd
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 26.2.2016 |
| 24.2.2016 | Odomzo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1030 | 26.2.2016 |
| 24.2.2016 | Peyona | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/09/528 | 26.2.2016 |
| 24.2.2016 | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 3.3.2016 |
| 24.2.2016 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 26.2.2016 |
| 24.2.2016 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | 26.2.2016 |
| 24.2.2016 | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 26.2.2016 |
| 24.2.2016 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 26.2.2016 |
| 25.2.2016 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/974 | 1.3.2016 |
| 26.2.2016 | Bridion | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/466 | 1.3.2016 |
| 26.2.2016 | Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 1.3.2016 |
| 26.2.2016 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 1.3.2016 |
| 26.2.2016 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/06/380 | 1.3.2016 |
| 26.2.2016 | Urorec | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/608 | 1.3.2016 |
| 26.2.2016 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 2.3.2016 |
| 26.2.2016 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/01/200 | 1.3.2016 |

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

8.2.2016

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/251

10.2.2016

8.2.2016

Irbesartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

10.2.2016

8.2.2016

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

10.2.2016

8.2.2016

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

10.2.2016

8.2.2016

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

10.2.2016

8.2.2016

Zoledronic acid Accord

Accord Healthcare Limited

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

EU/1/13/834

10.2.2016

11.2.2016

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/952

15.2.2016

11.2.2016

Simbrinza

Alcon Laboratories (UK) Ltd

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

EU/1/14/933

15.2.2016

11.2.2016

Sutent

Pfizer Limited

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

EU/1/06/347

15.2.2016

11.2.2016

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/04/305

15.2.2016

11.2.2016

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/883

15.2.2016

11.2.2016

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

15.2.2016

11.2.2016

Zoledronic acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

15.2.2016

11.2.2016

Zostavax

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

15.2.2016

11.2.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

15.2.2016

15.2.2016

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom

EU/1/14/913

17.2.2016

15.2.2016

Rivastigmine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/693

17.2.2016

18.2.2016

Aldara

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/98/080

22.2.2016

18.2.2016

Benlysta

Glaxo Group Ltd

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

EU/1/11/700

22.2.2016

18.2.2016

Biopoin

Teva GmbH

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

EU/1/09/565

22.2.2016

18.2.2016

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

22.2.2016

18.2.2016

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

22.2.2016

18.2.2016

Hizentra

CSL Behring GmbH

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

EU/1/11/687

22.2.2016

18.2.2016

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

22.2.2016

18.2.2016

Lojuxta

Aegerion Pharmaceuticals Limited

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

EU/1/13/851

22.2.2016

18.2.2016

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

22.2.2016

18.2.2016

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

22.2.2016

18.2.2016

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

22.2.2016

18.2.2016

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

22.2.2016

18.2.2016

TOBI Podhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/652

22.2.2016

18.2.2016

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

22.2.2016

18.2.2016

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

22.2.2016

22.2.2016

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

24.2.2016

22.2.2016

Constella

Allergan Pharmaceuticals International Ltd

Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland

EU/1/12/801

24.2.2016

22.2.2016

Eporatio

ratiopharm GmbH

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

EU/1/09/573

24.2.2016

22.2.2016

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/00/170

24.2.2016

22.2.2016

Herceptin

Roche Registration Limited

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

EU/1/00/145

24.2.2016

22.2.2016

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

24.2.2016

22.2.2016

Scintimun

CIS bio international

Boîte postale 32, F-91192 Gif-sur-Yvette, France

EU/1/09/602

24.2.2016

22.2.2016

Tygacil

Pfizer Limited

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

EU/1/06/336

24.2.2016

22.2.2016

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

24.2.2016

22.2.2016

Zoledronic acid Mylan

Mylan S.A.S

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

EU/1/12/786

24.2.2016

24.2.2016

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/538

26.2.2016

24.2.2016

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

26.2.2016

24.2.2016

Firdapse

BioMarin Europe Ltd

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

26.2.2016

24.2.2016

Odomzo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1030

26.2.2016

24.2.2016

Peyona

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

26.2.2016

24.2.2016

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

3.3.2016

24.2.2016

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

26.2.2016

24.2.2016

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

26.2.2016

24.2.2016

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

26.2.2016

24.2.2016

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

26.2.2016

25.2.2016

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/974

1.3.2016

26.2.2016

Bridion

Merck Sharp & Dohme Limited

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

EU/1/08/466

1.3.2016

26.2.2016

Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover)

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

1.3.2016

26.2.2016

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

1.3.2016

26.2.2016

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

1.3.2016

26.2.2016

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608

1.3.2016

26.2.2016

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

2.3.2016

26.2.2016

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/01/200

1.3.2016

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

| 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 |
| --- | --- | --- | --- | --- |
| 24.2.2016 | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314 | 29.2.2016 |

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

24.2.2016

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314

29.2.2016

—   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 |
| --- | --- | --- | --- | --- |
| 10.2.2016 | Zactran | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/08/082 | 12.2.2016 |
| 25.2.2016 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/137 | 29.2.2016 |
| 25.2.2016 | Vectra 3D | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/13/156 | 29.2.2016 |
| 25.2.2016 | Vectra Felis | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/14/165 | 29.2.2016 |
| 26.2.2016 | Econor | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/010 | 1.3.2016 |
| 26.2.2016 | Trifexis | Eli Lilly and Company Ltd, Elanco Animal Health
  Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/13/155 | 1.3.2016 |

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

10.2.2016

Zactran

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/082

12.2.2016

25.2.2016

Activyl Tick Plus

Intervet International B.V.

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

EU/2/11/137

29.2.2016

25.2.2016

Vectra 3D

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/13/156

29.2.2016

25.2.2016

Vectra Felis

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/14/165

29.2.2016

26.2.2016

Econor

Elanco Europe Ltd

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

EU/2/98/010

1.3.2016

26.2.2016

Trifexis

Eli Lilly and Company Ltd, Elanco Animal Health

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

EU/2/13/155

1.3.2016

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

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

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