# Službeni list C 361/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 361 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 58.30. listopada 2015. |

ISSN 1977-1088

Službeni list

Europske unije

C 361

Hrvatsko izdanje

Informacije i objave

Svezak 58.30. listopada 2015.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2015/C 361/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2015. do 30. rujna 2015.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2015/C 361/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2015. do 30. rujna 2015.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

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| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.10.2015 | HR | Službeni list Europske unije | C 361/1 |
| --- | --- | --- | --- |

30.10.2015

HR

Službeni list Europske unije

C 361/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. rujna 2015. do 30. rujna 2015.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2015/C 361/01)

—   Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.9.2015. | Ivabradine Anpharm | ivabradin | ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
  ul. Annopol 6B, 03–236 Warszawa, Polska | EU/1/15/1041 | Filmom obložena tableta | C01EB17 | 10.9.2015. |
| 8.9.2015. | Raxone | idebenon | Santhera Pharmaceuticals (Deutschland) GmbH
  Marie-Curie Strasse 8, 79539 Lörrach, Deutschland | EU/1/15/1020 | Filmom obložena tableta | N07 | 10.9.2015. |
| 14.9.2015. | Pemetrexed Lilly | pemetreksed | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/15/1034 | Primjena u venu | L01BA04 | 16.9.2015. |
| 17.9.2015. | Intuniv | gvanfacin | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1040 | Tablete s produženim oslobađanjem | C02AC02 | 21.9.2015. |
| 18.9.2015. | Pemetrexed Sandoz | pemetreksed | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1037 | Prašak za koncentrat za otopinu za infuziju | L01BA04 | 23.9.2015. |
| 18.9.2015. | Zalviso | Sufentanil | Grünenthal GmbH
  Zieglerstrasse 6, D-52078, Aachen, Deutschland | EU/1/15/1042 | Sublingvalno | N01AH03 | 22.9.2015. |
| 18.9.2015. | Zerbaxa | ceftolozan/tazobaktam | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1032 | Prašak za koncentrat za otopinu za infuziju | J01DI54 | 22.9.2015. |
| 23.9.2015. | Fexeric | ijzercitraat-coördinatiecomplex | Keryx Biopharma UK Ltd.
  Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom | EU/1/15/1039 | Filmom obložena tableta | V03AE | 28.9.2015. |
| 23.9.2015. | Praluent | alirokumab | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/15/1031 | Otopina za injekciju | C10 | 25.9.2015. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

8.9.2015.

Ivabradine Anpharm

ivabradin

ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.

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

EU/1/15/1041

Filmom obložena tableta

C01EB17

10.9.2015.

8.9.2015.

Raxone

idebenon

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Strasse 8, 79539 Lörrach, Deutschland

EU/1/15/1020

Filmom obložena tableta

N07

10.9.2015.

14.9.2015.

Pemetrexed Lilly

pemetreksed

Eli Lilly Nederland B.V.

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

EU/1/15/1034

Primjena u venu

L01BA04

16.9.2015.

17.9.2015.

Intuniv

gvanfacin

Shire Pharmaceuticals Ireland Limited

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

EU/1/15/1040

Tablete s produženim oslobađanjem

C02AC02

21.9.2015.

18.9.2015.

Pemetrexed Sandoz

pemetreksed

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1037

Prašak za koncentrat za otopinu za infuziju

L01BA04

23.9.2015.

18.9.2015.

Zalviso

Sufentanil

Grünenthal GmbH

Zieglerstrasse 6, D-52078, Aachen, Deutschland

EU/1/15/1042

Sublingvalno

N01AH03

22.9.2015.

18.9.2015.

Zerbaxa

ceftolozan/tazobaktam

Merck Sharp & Dohme Limited

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

EU/1/15/1032

Prašak za koncentrat za otopinu za infuziju

J01DI54

22.9.2015.

23.9.2015.

Fexeric

ijzercitraat-coördinatiecomplex

Keryx Biopharma UK Ltd.

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

EU/1/15/1039

Filmom obložena tableta

V03AE

28.9.2015.

23.9.2015.

Praluent

alirokumab

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/15/1031

Otopina za injekciju

C10

25.9.2015.

—   Izmjena odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

—   Povlačenje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 23.9.2015. | Biograstim | AbZ-Pharma GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/450 | 25.9.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

23.9.2015.

Biograstim

AbZ-Pharma GmbH

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

EU/1/08/450

25.9.2015.

—   Izdavanje odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | Tableta | QC09BX90 | 10.9.2015. |
| 8.9.2015. | Novaquin | meloksikam | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/15/186 | Peroralna suspenzija | QM01AC06 | 10.9.2015. |
| 8.9.2015. | Vectormune ND | Stanično vezani živi rekombinantni herpesvirus purana (rHVT/ND) izražen kao fuzijski protein lentogenog soja virusa D-26 newcastleske bolesti | CEVA-Phylaxia Co. Ltd.
  Budapest, Szállás u. 5, 1107 MAGYARORSZÁG | EU/2/15/188 | Suspenzija i otapalo za suspenziju za injekciju | QI01AD | 10.9.2015. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

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

Tableta

QC09BX90

10.9.2015.

8.9.2015.

Novaquin

meloksikam

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/15/186

Peroralna suspenzija

QM01AC06

10.9.2015.

8.9.2015.

Vectormune ND

Stanično vezani živi rekombinantni herpesvirus purana (rHVT/ND) izražen kao fuzijski protein lentogenog soja virusa D-26 newcastleske bolesti

CEVA-Phylaxia Co. Ltd.

Budapest, Szállás u. 5, 1107 MAGYARORSZÁG

EU/2/15/188

Suspenzija i otapalo za suspenziju za injekciju

QI01AD

10.9.2015.

—   Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:

| 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)  SL L 136, 30.4.2004., str. 1.

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