# Europos Sąjungos C 35/2016

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 35 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 59 tomas2016m. sausio 29d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 35

Leidimas lietuvių kalba

Informacija ir pranešimai

59 tomas2016m. sausio 29d.

---

| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2016/C 035/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gruodžio 1 d. iki 2015 m. gruodžio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2016/C 035/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gruodžio 1 d. iki 2015 m. gruodžio 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 29.1.2016 | LT | Europos Sąjungos oficialusis leidinys | C 35/1 |
| --- | --- | --- | --- |

29.1.2016

LT

Europos Sąjungos oficialusis leidinys

C 35/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2015 m. gruodžio 1 d. iki 2015 m. gruodžio 31 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)

(2016/C 035/01)

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2015 12 2 | Ciambra | Pemetreksedo | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/15/1055 | Milteliai koncentratui infuziniam tirpalui | L01BA04 | 2015 12 4 |
| 2015 12 2 | Nucala | Mepolizumabas | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | ES/1/15/1043 | Milteliai injekciniam tirpalui | Pending | 2015 12 7 |
| 2015 12 16 | Imlygic | Talimogenas laherparepvekas | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | ES/1/15/1064 | Injekcinis tirpalas | Pending | 2015 12 18 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2015 12 2

Ciambra

Pemetreksedo

Menarini International Operations Luxembourg S.A.

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

ES/1/15/1055

Milteliai koncentratui infuziniam tirpalui

L01BA04

2015 12 4

2015 12 2

Nucala

Mepolizumabas

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

ES/1/15/1043

Milteliai injekciniam tirpalui

Pending

2015 12 7

2015 12 16

Imlygic

Talimogenas laherparepvekas

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

ES/1/15/1064

Injekcinis tirpalas

Pending

2015 12 18

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Atmesta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 12 21 | Heparesc | Cytonet GmbH & Co. KG
  Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland | — | 2015 12 23 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 12 21

Heparesc

Cytonet GmbH & Co. KG

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

—

2015 12 23

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 12 2 | Tadalafil Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | ES/1/14/961 | 2015 12 4 |
| 2015 12 2 | Twinrix Adult | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/96/020 | 2015 12 4 |
| 2015 12 2 | Twinrix Paediatric | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/97/029 | 2015 12 4 |
| 2015 12 2 | Zyclara | MEDA AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | ES/1/12/783 | 2015 12 4 |
| 2015 12 9 | Abasaglar | Eli Lilly Regional Operations GmbH.
  Kölblgasse 8–10, 1030 Wien, Österreich | ES/1/14/944 | 2015 12 11 |
| 2015 12 9 | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/13/835 | 2015 12 11 |
| 2015 12 10 | Accofil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/14/946 | 2015 12 14 |
| 2015 12 10 | Amyvid | Eli Lilly Nederland B.V.
  Grootslag 1–5, NL-3991 RA Houten, Nederland | ES/1/12/805 | 2015 12 14 |
| 2015 12 10 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/07/419 | 2015 12 14 |
| 2015 12 10 | Efient | DAIICHI SANKYO EUROPE GmbH
  Zielstattstrasse 48, D-81379 München, Deutschland | ES/1/08/503 | 2015 12 14 |
| 2015 12 10 | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/357 | 2015 12 14 |
| 2015 12 10 | Holoclar | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/987 | 2015 12 14 |
| 2015 12 10 | Ifirmasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/08/480 | 2015 12 14 |
| 2015 12 10 | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26–28, H-1023 Budapest, Magyarország | ES/1/13/853 | 2015 12 14 |
| 2015 12 10 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/06/358 | 2015 12 14 |
| 2015 12 10 | Starlix | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/01/174 | 2015 12 14 |
| 2015 12 10 | Synagis | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | ES/1/99/117 | 2015 12 14 |
| 2015 12 10 | Vipidia | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/13/844 | 2015 12 14 |
| 2015 12 10 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/11/710 | 2015 12 14 |
| 2015 12 10 | Zoledronic acid Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76–78, 220 Hafnarfjörður, Ísland | ES/1/12/759 | 2015 12 14 |
| 2015 12 14 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | ES/1/07/430 | 2015 12 16 |
| 2015 12 14 | Envarsus | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/935 | 2015 12 16 |
| 2015 12 14 | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/14/922 | 2015 12 16 |
| 2015 12 14 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | ES/1/14/930 | 2015 12 16 |
| 2015 12 14 | Pandemrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/08/452 | 2015 12 16 |
| 2015 12 14 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/11/698 | 2015 12 16 |
| 2015 12 16 | Aldurazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | ES/1/03/253 | 2015 12 18 |
| 2015 12 16 | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | ES/1/04/289 | 2015 12 18 |
| 2015 12 16 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | ES/1/13/838 | 2015 12 18 |
| 2015 12 16 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/11/696 | 2015 12 18 |
| 2015 12 16 | Byetta | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/06/362 | 2015 12 18 |
| 2015 12 16 | Caprelsa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | ES/1/11/749 | 2015 12 18 |
| 2015 12 16 | Cholestagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | ES/1/03/268 | 2015 12 18 |
| 2015 12 16 | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/09/544 | 2015 12 18 |
| 2015 12 16 | Emend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/03/262 | 2015 12 18 |
| 2015 12 16 | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/07/425 | 2015 12 18 |
| 2015 12 16 | Fuzeon | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | ES/1/03/252 | 2015 12 18 |
| 2015 12 16 | Galvus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/07/414 | 2015 12 18 |
| 2015 12 16 | Icandra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/08/484 | 2015 12 18 |
| 2015 12 16 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/13/884 | 2015 12 18 |
| 2015 12 16 | Jalra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/08/485 | 2015 12 18 |
| 2015 12 16 | Kentera | Nicobrand Limited
  189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom | ES/1/03/270 | 2015 12 21 |
| 2015 12 16 | Lyrica | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/04/279 | 2015 12 18 |
| 2015 12 16 | Nimenrix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/12/767 | 2015 12 18 |
| 2015 12 16 | ProQuad | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/05/323 | 2015 12 18 |
| 2015 12 16 | Protopic | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | ES/1/02/201 | 2015 12 18 |
| 2015 12 16 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | ES/1/13/858 | 2015 12 18 |
| 2015 12 16 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | ES/1/13/837 | 2015 12 22 |
| 2015 12 16 | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | ES/1/02/212 | 2015 12 18 |
| 2015 12 16 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/14/918 | 2015 12 18 |
| 2015 12 16 | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | ES/1/11/672 | 2015 12 18 |
| 2015 12 16 | Xiliarx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/08/486 | 2015 12 18 |
| 2015 12 16 | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | ES/1/08/483 | 2015 12 18 |
| 2015 12 16 | Zutectra | Biotest Pharma GmbH
  Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | ES/1/09/600 | 2015 12 18 |
| 2015 12 18 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | ES/1/14/958 | 2015 12 22 |
| 2015 12 18 | Zostavax | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | ES/1/06/341 | 2015 12 22 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 12 2

Tadalafil Mylan

Generics [UK] Limited

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

ES/1/14/961

2015 12 4

2015 12 2

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/96/020

2015 12 4

2015 12 2

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/97/029

2015 12 4

2015 12 2

Zyclara

MEDA AB

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

ES/1/12/783

2015 12 4

2015 12 9

Abasaglar

Eli Lilly Regional Operations GmbH.

Kölblgasse 8–10, 1030 Wien, Österreich

ES/1/14/944

2015 12 11

2015 12 9

Voriconazole Accord

Accord Healthcare Limited

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

ES/1/13/835

2015 12 11

2015 12 10

Accofil

Accord Healthcare Limited

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

ES/1/14/946

2015 12 14

2015 12 10

Amyvid

Eli Lilly Nederland B.V.

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

ES/1/12/805

2015 12 14

2015 12 10

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/07/419

2015 12 14

2015 12 10

Efient

DAIICHI SANKYO EUROPE GmbH

Zielstattstrasse 48, D-81379 München, Deutschland

ES/1/08/503

2015 12 14

2015 12 10

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/357

2015 12 14

2015 12 10

Holoclar

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/987

2015 12 14

2015 12 10

Ifirmasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/08/480

2015 12 14

2015 12 10

Remsima

Celltrion Healthcare Hungary Kft.

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

ES/1/13/853

2015 12 14

2015 12 10

Silgard

Merck Sharp & Dohme Limited

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

ES/1/06/358

2015 12 14

2015 12 10

Starlix

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/01/174

2015 12 14

2015 12 10

Synagis

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

ES/1/99/117

2015 12 14

2015 12 10

Vipidia

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/13/844

2015 12 14

2015 12 10

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/11/710

2015 12 14

2015 12 10

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76–78, 220 Hafnarfjörður, Ísland

ES/1/12/759

2015 12 14

2015 12 14

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

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

ES/1/07/430

2015 12 16

2015 12 14

Envarsus

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/935

2015 12 16

2015 12 14

Incruse

Glaxo Group Ltd

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

ES/1/14/922

2015 12 16

2015 12 14

Jardiance

Boehringer Ingelheim International GmbH

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

ES/1/14/930

2015 12 16

2015 12 14

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/08/452

2015 12 16

2015 12 14

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

ES/1/11/698

2015 12 16

2015 12 16

Aldurazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

ES/1/03/253

2015 12 18

2015 12 16

Angiox

The Medicines Company UK Ltd

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

ES/1/04/289

2015 12 18

2015 12 16

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

ES/1/13/838

2015 12 18

2015 12 16

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/11/696

2015 12 18

2015 12 16

Byetta

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/06/362

2015 12 18

2015 12 16

Caprelsa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

ES/1/11/749

2015 12 18

2015 12 16

Cholestagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

ES/1/03/268

2015 12 18

2015 12 16

Cimzia

UCB Pharma S.A.

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

ES/1/09/544

2015 12 18

2015 12 16

Emend

Merck Sharp & Dohme Limited

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

ES/1/03/262

2015 12 18

2015 12 16

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/07/425

2015 12 18

2015 12 16

Fuzeon

Roche Registration Limited

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

ES/1/03/252

2015 12 18

2015 12 16

Galvus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/07/414

2015 12 18

2015 12 16

Icandra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/08/484

2015 12 18

2015 12 16

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/13/884

2015 12 18

2015 12 16

Jalra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/08/485

2015 12 18

2015 12 16

Kentera

Nicobrand Limited

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

ES/1/03/270

2015 12 21

2015 12 16

Lyrica

Pfizer Limited

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

ES/1/04/279

2015 12 18

2015 12 16

Nimenrix

Pfizer Limited

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

ES/1/12/767

2015 12 18

2015 12 16

ProQuad

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/05/323

2015 12 18

2015 12 16

Protopic

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

ES/1/02/201

2015 12 18

2015 12 16

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

ES/1/13/858

2015 12 18

2015 12 16

Tecfidera

Biogen Idec Limited

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

ES/1/13/837

2015 12 22

2015 12 16

Vfend

Pfizer Limited

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

ES/1/02/212

2015 12 18

2015 12 16

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/14/918

2015 12 18

2015 12 16

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

ES/1/11/672

2015 12 18

2015 12 16

Xiliarx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/08/486

2015 12 18

2015 12 16

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

ES/1/08/483

2015 12 18

2015 12 16

Zutectra

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

ES/1/09/600

2015 12 18

2015 12 18

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

ES/1/14/958

2015 12 22

2015 12 18

Zostavax

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

ES/1/06/341

2015 12 22

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 12 16 | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | ES/1/01/179 | 2015 12 21 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 12 16

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

ES/1/01/179

2015 12 21

—   Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2015 12 9 | Imrestor | pegbovigrastimas | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | ES/2/15/193 | Injekcinis tirpalas | QL03AA90 | 2015 12 11 |
| 2015 12 9 | Velactis | Kabergolinas | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | ES/2/15/192 | Injekcinis tirpalas | QG02CB03 | 2015 12 11 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2015 12 9

Imrestor

pegbovigrastimas

Eli Lilly and Company Limited

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

ES/2/15/193

Injekcinis tirpalas

QL03AA90

2015 12 11

2015 12 9

Velactis

Kabergolinas

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

ES/2/15/192

Injekcinis tirpalas

QG02CB03

2015 12 11

—   Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2015 12 2 | Easotic | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France | ES/2/08/085 | 2015 12 4 |
| 2015 12 2 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | ES/2/11/134 | 2015 12 4 |
| 2015 12 2 | Purevax Rabies | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/10/117 | 2015 12 4 |
| 2015 12 18 | Equip WNV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/08/086 | 2015 12 21 |
| 2015 12 18 | Novem | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | ES/2/04/042 | 2015 12 22 |
| 2015 12 18 | Purevax RC | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | ES/2/04/051 | 2015 12 22 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2015 12 2

Easotic

VIRBAC S.A.

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

ES/2/08/085

2015 12 4

2015 12 2

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

ES/2/11/134

2015 12 4

2015 12 2

Purevax Rabies

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/10/117

2015 12 4

2015 12 18

Equip WNV

Zoetis Belgium S.A.

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

ES/2/08/086

2015 12 21

2015 12 18

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

ES/2/04/042

2015 12 22

2015 12 18

Purevax RC

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

ES/2/04/051

2015 12 22

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

| 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)  OL L 136, 2004 4 30, p. 1.

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