# Eiropas Savienības C 35/2016

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 35 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 59. sējums2016. gada 29. janvāris |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 35

Izdevums latviešu valodā

Informācija un paziņojumi

59. sējums2016. gada 29. janvāris

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2016/C 035/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. decembra līdz 2015. gada 31. decembrim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2016/C 035/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. decembra līdz 2015. gada 31. decembrim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

1

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| LV | |
| --- | --- |

LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 29.1.2016 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 35/1 |
| --- | --- | --- | --- |

29.1.2016

LV

Eiropas Savienības Oficiālais Vēstnesis

C 35/1

---

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. decembra līdz 2015. gada 31. decembrim

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)

(2016/C 035/01)

—   Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | L01BA04 | 4.12.2015. |
| 2.12.2015. | Nucala | mepolizumabs | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | Pulveris injekciju šķīduma pagatavošanai | Pending | 7.12.2015. |
| 16.12.2015. | Imlygic | talimogēna laherparepveks | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1064 | Šķīdums injekcijai | Pending | 18.12.2015. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

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

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01BA04

4.12.2015.

2.12.2015.

Nucala

mepolizumabs

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

Pulveris injekciju šķīduma pagatavošanai

Pending

7.12.2015.

16.12.2015.

Imlygic

talimogēna laherparepveks

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1064

Šķīdums injekcijai

Pending

18.12.2015.

—   Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 21.12.2015. | Heparesc | Cytonet GmbH & Co. KG
  Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland | — | 23.12.2015. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

21.12.2015.

Heparesc

Cytonet GmbH & Co. KG

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

—

23.12.2015.

—   Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 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 Paris, 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. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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 Paris, 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.

—   Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 16.12.2015. | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/01/179 | 21.12.2015. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

16.12.2015.

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/01/179

21.12.2015.

—   Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | Šķīdums injekcijai | QL03AA90 | 11.12.2015. |
| 9.12.2015. | Velactis | Cabergoline | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | EU/2/15/192 | Šķīdums injekcijai | QG02CB03 | 11.12.2015. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

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

Šķīdums injekcijai

QL03AA90

11.12.2015.

9.12.2015.

Velactis

Cabergoline

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

EU/2/15/192

Šķīdums injekcijai

QG02CB03

11.12.2015.

—   Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 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. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

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.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

| 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)  OV L 136, 30.4.2004, 1. lpp.

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