# Official Journal C 361/30 O

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 361 |
| | |
| English edition | Information and Notices | Volume 5830 October 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 361

English edition

Information and Notices

Volume 5830 October 2015

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 361/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 2015(Published pursuant to Article 13 or Article 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

2015/C 361/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

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| EN | |
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EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.10.2015 | EN | Official Journal of the European Union | C 361/1 |
| --- | --- | --- | --- |

30.10.2015

EN

Official Journal of the European Union

C 361/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2015 to 30 September 2015

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

(2015/C 361/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.9.2015 | Ivabradine Anpharm | ivabradine | ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
  ul. Annopol 6B, 03-236 Warszawa, Polska | EU/1/15/1041 | Film-coated tablet | C01EB17 | 10.9.2015 |
| 8.9.2015 | Raxone | idebenone | Santhera Pharmaceuticals (Deutschland) GmbH
  Marie-Curie Strasse 8, 79539 Lörrach, Deutschland | EU/1/15/1020 | Film-coated tablet | N07 | 10.9.2015 |
| 14.9.2015 | Pemetrexed Lilly | pemetrexed | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/15/1034 | Intravenous use | L01BA04 | 16.9.2015 |
| 17.9.2015 | Intuniv | guanfacine | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1040 | Prolonged-release tablet | C02AC02 | 21.9.2015 |
| 18.9.2015 | Pemetrexed Sandoz | pemetrexed | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1037 | Powder for concentrate for solution for infusion | L01BA04 | 23.9.2015 |
| 18.9.2015 | Zalviso | Sufentanil | Grünenthal GmbH
  Zieglerstrasse 6, D-52078, Aachen, Deutschland | EU/1/15/1042 | Sublingual tablet | N01AH03 | 22.9.2015 |
| 18.9.2015 | Zerbaxa | ceftolozane/tazobactam | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1032 | Powder for concentrate for solution for infusion | J01DI54 | 22.9.2015 |
| 23.9.2015 | Fexeric | ferric citrate coordination complex | Keryx Biopharma UK Ltd
  Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom | EU/1/15/1039 | Film-coated tablet | V03AE | 28.9.2015 |
| 23.9.2015 | Praluent | alirocumab | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/15/1031 | Solution for injection | C10 | 25.9.2015 |

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

8.9.2015

Ivabradine Anpharm

ivabradine

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

ul. Annopol 6B, 03-236 Warszawa, Polska

EU/1/15/1041

Film-coated tablet

C01EB17

10.9.2015

8.9.2015

Raxone

idebenone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Strasse 8, 79539 Lörrach, Deutschland

EU/1/15/1020

Film-coated tablet

N07

10.9.2015

14.9.2015

Pemetrexed Lilly

pemetrexed

Eli Lilly Nederland B.V.

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

EU/1/15/1034

Intravenous use

L01BA04

16.9.2015

17.9.2015

Intuniv

guanfacine

Shire Pharmaceuticals Ireland Limited

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

EU/1/15/1040

Prolonged-release tablet

C02AC02

21.9.2015

18.9.2015

Pemetrexed Sandoz

pemetrexed

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1037

Powder for concentrate for solution for infusion

L01BA04

23.9.2015

18.9.2015

Zalviso

Sufentanil

Grünenthal GmbH

Zieglerstrasse 6, D-52078, Aachen, Deutschland

EU/1/15/1042

Sublingual tablet

N01AH03

22.9.2015

18.9.2015

Zerbaxa

ceftolozane/tazobactam

Merck Sharp & Dohme Limited

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

EU/1/15/1032

Powder for concentrate for solution for infusion

J01DI54

22.9.2015

23.9.2015

Fexeric

ferric citrate coordination complex

Keryx Biopharma UK Ltd

Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom

EU/1/15/1039

Film-coated tablet

V03AE

28.9.2015

23.9.2015

Praluent

alirocumab

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/15/1031

Solution for injection

C10

25.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 8.9.2015 | ATryn | GTC Biotherapeutics UK Limited
  10 Norwich Street, London EC4A 1BD, United Kingdom | EU/1/06/355 | 10.9.2015 |
| 8.9.2015 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 10.9.2015 |
| 8.9.2015 | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/02/219 | 10.9.2015 |
| 8.9.2015 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 10.9.2015 |
| 8.9.2015 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 10.9.2015 |
| 8.9.2015 | Extavia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/454 | 10.9.2015 |
| 8.9.2015 | Grastofil | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/13/877 | 10.9.2015 |
| 8.9.2015 | Hirobriz Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/594 | 10.9.2015 |
| 8.9.2015 | Plegridy | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | 10.9.2015 |
| 8.9.2015 | Xofigo | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/873 | 10.9.2015 |
| 8.9.2015 | Xyrem | UCB Pharma Ltd
  208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312 | 10.9.2015 |
| 10.9.2015 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 14.9.2015 |
| 14.9.2015 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 16.9.2015 |
| 14.9.2015 | Elaprase | Shire Human Genetic Therapies AB
  Svärdvägen 11D, SE-182 33 Danderyd, Sverige | EU/1/06/365 | 16.9.2015 |
| 14.9.2015 | Quinsair | Aptalis Pharma SAS
  Route de Bû, F-78550 Houdan, France | EU/1/14/973 | 16.9.2015 |
| 18.9.2015 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 22.9.2015 |
| 18.9.2015 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 22.9.2015 |
| 18.9.2015 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | EU/1/13/855 | 22.9.2015 |
| 18.9.2015 | INOmax | Linde Healthcare AB
  SE-181 81 Lidingö, Sverige | EU/1/01/194 | 22.9.2015 |
| 18.9.2015 | Metalyse | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/00/169 | 22.9.2015 |
| 18.9.2015 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 22.9.2015 |
| 18.9.2015 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 22.9.2015 |
| 18.9.2015 | Sebivo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/388 | 22.9.2015 |
| 18.9.2015 | Spedra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/13/841 | 22.9.2015 |
| 18.9.2015 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277 | 22.9.2015 |
| 18.9.2015 | Visudyne | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/00/140 | 22.9.2015 |
| 23.9.2015 | Ilaris | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/564 | 28.10.2015 |
| 23.9.2015 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/13/854 | 25.9.2015 |
| 23.9.2015 | Toviaz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/386 | 25.9.2015 |
| 23.9.2015 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 25.9.2015 |
| 23.9.2015 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 28.9.2015 |
| 30.9.2015 | Arixtra | Aspen Pharma Trading Limited
  3016 Lake Drive Citywest Business Campus Dublin 24 Ireland | EU/1/02/206 | 2.10.2015 |
| 30.9.2015 | Iasibon | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/10/659 | 2.10.2015 |
| 30.9.2015 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050 | 2.10.2015 |
| 30.9.2015 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 2.10.2015 |

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

8.9.2015

ATryn

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355

10.9.2015

8.9.2015

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

10.9.2015

8.9.2015

Ebixa

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/02/219

10.9.2015

8.9.2015

Enbrel

Pfizer Limited

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

EU/1/99/126

10.9.2015

8.9.2015

Esbriet

Roche Registration Limited

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

EU/1/11/667

10.9.2015

8.9.2015

Extavia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/454

10.9.2015

8.9.2015

Grastofil

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/13/877

10.9.2015

8.9.2015

Hirobriz Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/594

10.9.2015

8.9.2015

Plegridy

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/14/934

10.9.2015

8.9.2015

Xofigo

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/873

10.9.2015

8.9.2015

Xyrem

UCB Pharma Ltd

208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312

10.9.2015

10.9.2015

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

14.9.2015

14.9.2015

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

16.9.2015

14.9.2015

Elaprase

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/06/365

16.9.2015

14.9.2015

Quinsair

Aptalis Pharma SAS

Route de Bû, F-78550 Houdan, France

EU/1/14/973

16.9.2015

18.9.2015

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

22.9.2015

18.9.2015

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

22.9.2015

18.9.2015

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark

EU/1/13/855

22.9.2015

18.9.2015

INOmax

Linde Healthcare AB

SE-181 81 Lidingö, Sverige

EU/1/01/194

22.9.2015

18.9.2015

Metalyse

Boehringer Ingelheim International GmbH

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

EU/1/00/169

22.9.2015

18.9.2015

Perjeta

Roche Registration Limited

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

EU/1/13/813

22.9.2015

18.9.2015

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

22.9.2015

18.9.2015

Sebivo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/388

22.9.2015

18.9.2015

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/13/841

22.9.2015

18.9.2015

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277

22.9.2015

18.9.2015

Visudyne

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/00/140

22.9.2015

23.9.2015

Ilaris

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/564

28.10.2015

23.9.2015

Inflectra

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/13/854

25.9.2015

23.9.2015

Toviaz

Pfizer Limited

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

EU/1/07/386

25.9.2015

23.9.2015

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

25.9.2015

23.9.2015

Viagra

Pfizer Limited

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

EU/1/98/077

28.9.2015

30.9.2015

Arixtra

Aspen Pharma Trading Limited

3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

EU/1/02/206

2.10.2015

30.9.2015

Iasibon

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

2.10.2015

30.9.2015

Sifrol

Boehringer Ingelheim International GmbH

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

EU/1/97/050

2.10.2015

30.9.2015

Vibativ

Clinigen Healthcare Limited

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

EU/1/11/705

2.10.2015

—   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 |
| --- | --- | --- | --- | --- |
| 23.9.2015 | Biograstim | AbZ-Pharma GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/450 | 25.9.2015 |

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

23.9.2015

Biograstim

AbZ-Pharma GmbH

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

EU/1/08/450

25.9.2015

—   Issuing 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.9.2015 | FORTEKOR PLUS | pimobendan/benazepril | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom | EU/2/15/185 | Tablet | QC09BX90 | 10.9.2015 |
| 8.9.2015 | Novaquin | meloxicam | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/15/186 | Oral suspension | QM01AC06 | 10.9.2015 |
| 8.9.2015 | Vectormune ND | Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain | CEVA-Phylaxia Co. Ltd
  Budapest, Szállás u. 5, 1107 MAGYARORSZÁG | EU/2/15/188 | Suspension and solvent for suspension for injection | QI01AD | 10.9.2015 |

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

8.9.2015

FORTEKOR PLUS

pimobendan/benazepril

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom

EU/2/15/185

Tablet

QC09BX90

10.9.2015

8.9.2015

Novaquin

meloxicam

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/15/186

Oral suspension

QM01AC06

10.9.2015

8.9.2015

Vectormune ND

Cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain

CEVA-Phylaxia Co. Ltd

Budapest, Szállás u. 5, 1107 MAGYARORSZÁG

EU/2/15/188

Suspension and solvent for suspension for injection

QI01AD

10.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 8.9.2015 | BTVPUR AlSap 1 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/112 | 10.9.2015 |
| 8.9.2015 | BTVPUR AlSap 1-8 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/113 | 10.9.2015 |
| 8.9.2015 | Meloxoral | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/10/111 | 10.9.2015 |
| 18.9.2015 | Onsior | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom | EU/2/08/089 | 22.9.2015 |

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

8.9.2015

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/112

10.9.2015

8.9.2015

BTVPUR AlSap 1-8

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

10.9.2015

8.9.2015

Meloxoral

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/10/111

10.9.2015

18.9.2015

Onsior

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom

EU/2/08/089

22.9.2015

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

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

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