# Il-Ġurnal Uffiċjali C 35/29 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 35 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5929ta' Jannar 2016 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 35

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5929ta' Jannar 2016

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2016/C 035/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Diċembru 2015 sal-31 ta’ Diċembru 2015(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2016/C 035/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Diċembru 2015 sal-31 ta’ Diċembru 2015(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

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| MT | |
| --- | --- |

MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 29.1.2016 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 35/1 |
| --- | --- | --- | --- |

29.1.2016

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 35/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Diċembru 2015 sal-31 ta’ Diċembru 2015

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))

(2016/C 035/01)

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.12.2015 | Ciambra | pemetrexed | Menarini International Operations Lussemburgu S.A.
  1 avenue de la Gare, L-1611 Lussemburgu, Grand-Duché de Lussemburgu | EU/1/15/1055 | Trab għal konċentrat għal soluzzjoni għall-infużjoni | L01BA04 | 4.12.2015 |
| 2.12.2015 | Nucala | mepolizumab | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | Trab għal soluzzjoni għall-injezzjoni | 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 | Soluzzjoni għall-injezzjoni | Pending | 18.12.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta’ notifika

2.12.2015

Ciambra

pemetrexed

Menarini International Operations Lussemburgu S.A.

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

EU/1/15/1055

Trab għal konċentrat għal soluzzjoni għall-infużjoni

L01BA04

4.12.2015

2.12.2015

Nucala

mepolizumab

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

Trab għal soluzzjoni għall-injezzjoni

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

Soluzzjoni għall-injezzjoni

Pending

18.12.2015

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 21.12.2015 | Heparesc | Cytonet GmbH & Co. KG
  Albert-Ludwig-Grimm Straße 20, D-69469 Weinheim, Deutschland | — | 23.12.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

21.12.2015

Heparesc

Cytonet GmbH & Co. KG

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

—

23.12.2015

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 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 2 A, 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

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 2 A, 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

—   Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 16.12.2015 | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/01/179 | 21.12.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

16.12.2015

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/01/179

21.12.2015

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | Soluzzjoni għall-injezzjoni | QL03AA90 | 11.12.2015 |
| 9.12.2015 | Velactis | Cabergoline | Ceva Santé Animale
  10 av. de La Ballastière, 33500 Libourne, France | EU/2/15/192 | Soluzzjoni għall-injezzjoni | QG02CB03 | 11.12.2015 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta’ notifika

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

Soluzzjoni għall-injezzjoni

QL03AA90

11.12.2015

9.12.2015

Velactis

Cabergoline

Ceva Santé Animale

10 av. de La Ballastière, 33500 Libourne, France

EU/2/15/192

Soluzzjoni għall-injezzjoni

QG02CB03

11.12.2015

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

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

Kull min jixtieq jikkonsulta r-rapport ta’ evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.04, p. 1.

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