# Službeni list C 35/29.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 35 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 59.29. siječnja 2016. |

ISSN 1977-1088

Službeni list

Europske unije

C 35

Hrvatsko izdanje

Informacije i objave

Svezak 59.29. siječnja 2016.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2016/C 035/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2015. do 31. prosinca 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

2016/C 035/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2015. do 31. prosinca 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

| 29.1.2016 | HR | Službeni list Europske unije | C 35/1 |
| --- | --- | --- | --- |

29.1.2016

HR

Službeni list Europske unije

C 35/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2015. do 31. prosinca 2015.

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

(2016/C 035/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.12.2015. | Ciambra | pemetrekseda | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/1055 | Prašak za koncentrat za otopinu za infuziju | L01BA04 | 4.12.2015. |
| 2.12.2015. | Nucala | mepolizumab | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | Prašak za otopinu za injekciju | Pending | 7.12.2015. |
| 16.12.2015. | Imlygic | Talimogene laherparepvec | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1064 | Otopina za injekciju | Pending | 18.12.2015. |

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

2.12.2015.

Ciambra

pemetrekseda

Menarini International Operations Luxembourg S.A.

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

EU/1/15/1055

Prašak za koncentrat za otopinu za infuziju

L01BA04

4.12.2015.

2.12.2015.

Nucala

mepolizumab

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

Prašak za otopinu za injekciju

Pending

7.12.2015.

16.12.2015.

Imlygic

Talimogene laherparepvec

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1064

Otopina za injekciju

Pending

18.12.2015.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 21.12.2015. | Heparesc | Cytonet GmbH & Co. KG
  Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland | — | 23.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

21.12.2015.

Heparesc

Cytonet GmbH & Co. KG

Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland

—

23.12.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 2.12.2015. | Tadalafil Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | 4.12.2015. |
| 2.12.2015. | Twinrix Adult | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/96/020 | 4.12.2015. |
| 2.12.2015. | Twinrix Paediatric | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/97/029 | 4.12.2015. |
| 2.12.2015. | Zyclara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/12/783 | 4.12.2015. |
| 9.12.2015. | Abasaglar | Eli Lilly Regional Operations GmbH.
  Kölblgasse 8-10, 1030 Wien, Österreich | EU/1/14/944 | 11.12.2015. |
| 9.12.2015. | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 11.12.2015. |
| 10.12.2015. | Accofil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | 14.12.2015. |
| 10.12.2015. | Amyvid | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/12/805 | 14.12.2015. |
| 10.12.2015. | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 14.12.2015. |
| 10.12.2015. | Efient | DAIICHI SANKYO EUROPE GmbH
  Zielstattstrasse 48, D-81379 München, Deutschland | EU/1/08/503 | 14.12.2015. |
| 10.12.2015. | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 14.12.2015. |
| 10.12.2015. | Holoclar | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 14.12.2015. |
| 10.12.2015. | Ifirmasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/480 | 14.12.2015. |
| 10.12.2015. | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | 14.12.2015. |
| 10.12.2015. | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 14.12.2015. |
| 10.12.2015. | Starlix | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/174 | 14.12.2015. |
| 10.12.2015. | Synagis | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/99/117 | 14.12.2015. |
| 10.12.2015. | Vipidia | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/844 | 14.12.2015. |
| 10.12.2015. | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 14.12.2015. |
| 10.12.2015. | Zoledronic acid Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/12/759 | 14.12.2015. |
| 14.12.2015. | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 16.12.2015. |
| 14.12.2015. | Envarsus | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | 16.12.2015. |
| 14.12.2015. | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 16.12.2015. |
| 14.12.2015. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 16.12.2015. |
| 14.12.2015. | Pandemrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/08/452 | 16.12.2015. |
| 14.12.2015. | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 16.12.2015. |
| 16.12.2015. | Aldurazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/253 | 18.12.2015. |
| 16.12.2015. | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 18.12.2015. |
| 16.12.2015. | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Pariz, France | EU/1/13/838 | 18.12.2015. |
| 16.12.2015. | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 18.12.2015. |
| 16.12.2015. | Byetta | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/06/362 | 18.12.2015. |
| 16.12.2015. | Caprelsa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/749 | 18.12.2015. |
| 16.12.2015. | Cholestagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/268 | 18.12.2015. |
| 16.12.2015. | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 18.12.2015. |
| 16.12.2015. | Emend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262 | 18.12.2015. |
| 16.12.2015. | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/425 | 18.12.2015. |
| 16.12.2015. | Fuzeon | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/252 | 18.12.2015. |
| 16.12.2015. | Galvus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/414 | 18.12.2015. |
| 16.12.2015. | Icandra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/484 | 18.12.2015. |
| 16.12.2015. | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 18.12.2015. |
| 16.12.2015. | Jalra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/485 | 18.12.2015. |
| 16.12.2015. | Kentera | Nicobrand Limited
  189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom | EU/1/03/270 | 21.12.2015. |
| 16.12.2015. | Lyrica | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/04/279 | 18.12.2015. |
| 16.12.2015. | Nimenrix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/767 | 18.12.2015. |
| 16.12.2015. | ProQuad | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/05/323 | 18.12.2015. |
| 16.12.2015. | Protopic | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/02/201 | 18.12.2015. |
| 16.12.2015. | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 18.12.2015. |
| 16.12.2015. | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 22.12.2015. |
| 16.12.2015. | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212 | 18.12.2015. |
| 16.12.2015. | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 18.12.2015. |
| 16.12.2015. | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/672 | 18.12.2015. |
| 16.12.2015. | Xiliarx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/486 | 18.12.2015. |
| 16.12.2015. | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/483 | 18.12.2015. |
| 16.12.2015. | Zutectra | Biotest Pharma GmbH
  Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | EU/1/09/600 | 18.12.2015. |
| 18.12.2015. | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 22.12.2015. |
| 18.12.2015. | Zostavax | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 22.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.12.2015.

Tadalafil Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/14/961

4.12.2015.

2.12.2015.

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/96/020

4.12.2015.

2.12.2015.

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/97/029

4.12.2015.

2.12.2015.

Zyclara

Meda AB

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

EU/1/12/783

4.12.2015.

9.12.2015.

Abasaglar

Eli Lilly Regional Operations GmbH.

Kölblgasse 8-10, 1030 Wien, Österreich

EU/1/14/944

11.12.2015.

9.12.2015.

Voriconazole Accord

Accord Healthcare Limited

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

EU/1/13/835

11.12.2015.

10.12.2015.

Accofil

Accord Healthcare Limited

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

EU/1/14/946

14.12.2015.

10.12.2015.

Amyvid

Eli Lilly Nederland B.V.

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

EU/1/12/805

14.12.2015.

10.12.2015.

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

14.12.2015.

10.12.2015.

Efient

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48, D-81379 München, Deutschland

EU/1/08/503

14.12.2015.

10.12.2015.

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

14.12.2015.

10.12.2015.

Holoclar

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

14.12.2015.

10.12.2015.

Ifirmasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

14.12.2015.

10.12.2015.

Remsima

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

14.12.2015.

10.12.2015.

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

14.12.2015.

10.12.2015.

Starlix

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/174

14.12.2015.

10.12.2015.

Synagis

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/99/117

14.12.2015.

10.12.2015.

Vipidia

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/844

14.12.2015.

10.12.2015.

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

14.12.2015.

10.12.2015.

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/12/759

14.12.2015.

14.12.2015.

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

16.12.2015.

14.12.2015.

Envarsus

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

16.12.2015.

14.12.2015.

Incruse

Glaxo Group Ltd

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

EU/1/14/922

16.12.2015.

14.12.2015.

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

16.12.2015.

14.12.2015.

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/08/452

16.12.2015.

14.12.2015.

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

16.12.2015.

16.12.2015.

Aldurazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/253

18.12.2015.

16.12.2015.

Angiox

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

18.12.2015.

16.12.2015.

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Pariz, France

EU/1/13/838

18.12.2015.

16.12.2015.

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

18.12.2015.

16.12.2015.

Byetta

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/06/362

18.12.2015.

16.12.2015.

Caprelsa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/749

18.12.2015.

16.12.2015.

Cholestagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/268

18.12.2015.

16.12.2015.

Cimzia

UCB Pharma S.A.

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

EU/1/09/544

18.12.2015.

16.12.2015.

Emend

Merck Sharp & Dohme Limited

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

EU/1/03/262

18.12.2015.

16.12.2015.

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

18.12.2015.

16.12.2015.

Fuzeon

Roche Registration Limited

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

EU/1/03/252

18.12.2015.

16.12.2015.

Galvus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/414

18.12.2015.

16.12.2015.

Icandra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/484

18.12.2015.

16.12.2015.

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

18.12.2015.

16.12.2015.

Jalra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/485

18.12.2015.

16.12.2015.

Kentera

Nicobrand Limited

189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom

EU/1/03/270

21.12.2015.

16.12.2015.

Lyrica

Pfizer Limited

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

EU/1/04/279

18.12.2015.

16.12.2015.

Nimenrix

Pfizer Limited

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

EU/1/12/767

18.12.2015.

16.12.2015.

ProQuad

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/05/323

18.12.2015.

16.12.2015.

Protopic

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/02/201

18.12.2015.

16.12.2015.

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

18.12.2015.

16.12.2015.

Tecfidera

Biogen Idec Limited

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

EU/1/13/837

22.12.2015.

16.12.2015.

Vfend

Pfizer Limited

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

EU/1/02/212

18.12.2015.

16.12.2015.

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

18.12.2015.

16.12.2015.

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/672

18.12.2015.

16.12.2015.

Xiliarx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/486

18.12.2015.

16.12.2015.

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/483

18.12.2015.

16.12.2015.

Zutectra

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

EU/1/09/600

18.12.2015.

18.12.2015.

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

22.12.2015.

18.12.2015.

Zostavax

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

22.12.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 16.12.2015. | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/01/179 | 21.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

16.12.2015.

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/01/179

21.12.2015.

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.12.2015. | Imrestor | pegbovigrastim | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/15/193 | Otopina za injekciju | QL03AA90 | 11.12.2015. |
| 9.12.2015. | Velactis | Kabergolin | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | EU/2/15/192 | Otopina za injekciju | QG02CB03 | 11.12.2015. |

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

9.12.2015.

Imrestor

pegbovigrastim

Eli Lilly and Company Limited

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

EU/2/15/193

Otopina za injekciju

QL03AA90

11.12.2015.

9.12.2015.

Velactis

Kabergolin

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

EU/2/15/192

Otopina za injekciju

QG02CB03

11.12.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 2.12.2015. | Easotic | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/08/085 | 4.12.2015. |
| 2.12.2015. | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 4.12.2015. |
| 2.12.2015. | Purevax Rabies | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/117 | 4.12.2015. |
| 18.12.2015. | Equip WNV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/086 | 21.12.2015. |
| 18.12.2015. | Novem | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/04/042 | 22.12.2015. |
| 18.12.2015. | Purevax RC | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/051 | 22.12.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.12.2015.

Easotic

VIRBAC S.A.

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

EU/2/08/085

4.12.2015.

2.12.2015.

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

4.12.2015.

2.12.2015.

Purevax Rabies

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/117

4.12.2015.

18.12.2015.

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

21.12.2015.

18.12.2015.

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

22.12.2015.

18.12.2015.

Purevax RC

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/051

22.12.2015.

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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