# Službeni list C 30/26.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 30 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.26. siječnja 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 30

Hrvatsko izdanje

Informacije i objave

Godište 61.26. siječnja 2018.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 30/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2018/C 30/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 10 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2018/C 30/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.(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

2018/C 30/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

10

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 26.1.2018 | HR | Službeni list Europske unije | C 30/1 |
| --- | --- | --- | --- |

26.1.2018

HR

Službeni list Europske unije

C 30/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.

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

(2018/C 030/01)

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

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.12.2017. | Tacforius | takrolimus | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | Tvrda kapsula s produljenim oslobađanjem | L04AD02 | 12.12.2017. |
| 18.12.2017. | Alecensa | alektinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | Kapsula, tvrda | L01XE36 | 20.12.2017. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

8.12.2017.

Tacforius

takrolimus

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

Tvrda kapsula s produljenim oslobađanjem

L04AD02

12.12.2017.

18.12.2017.

Alecensa

alektinib

Roche Registration Limited

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

EU/1/16/1169

Kapsula, tvrda

L01XE36

20.12.2017.

—   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 |
| --- | --- | --- | --- | --- |
| 8.12.2017. | Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech | XBiotech Germany GmbH
  Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland | — | 12.12.2017. |
| 18.12.2017. | Masipro | AB Science
  3 avenue George V, 75008 Pariz, France | — | 20.12.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

8.12.2017.

Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

XBiotech Germany GmbH

Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland

—

12.12.2017.

18.12.2017.

Masipro

AB Science

3 avenue George V, 75008 Pariz, France

—

20.12.2017.

—   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 |
| --- | --- | --- | --- | --- |
| 1.12.2017. | Alecensa | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | 5.12.2017. |
| 1.12.2017. | Hetlioz | Vanda Pharmaceuticals Limited
  25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom | EU/1/15/1008 | 5.12.2017. |
| 1.12.2017. | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 5.12.2017. |
| 1.12.2017. | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 5.12.2017. |
| 1.12.2017. | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 5.12.2017. |
| 8.12.2017. | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 12.12.2017. |
| 8.12.2017. | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 12.12.2017. |
| 8.12.2017. | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 13.12.2017. |
| 8.12.2017. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 12.12.2017. |
| 8.12.2017. | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 12.12.2017. |
| 8.12.2017. | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 13.12.2017. |
| 8.12.2017. | Humira | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/03/256 | 12.12.2017. |
| 8.12.2017. | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 13.12.2017. |
| 8.12.2017. | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 12.12.2017. |
| 8.12.2017. | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 13.12.2017. |
| 8.12.2017. | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 12.12.2017. |
| 8.12.2017. | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 13.12.2017. |
| 8.12.2017. | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/14/962 | 12.12.2017. |
| 8.12.2017. | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 12.12.2017. |
| 8.12.2017. | Oncaspar | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/15/1070 | 14.12.2017. |
| 8.12.2017. | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 13.12.2017. |
| 8.12.2017. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 12.12.2017. |
| 8.12.2017. | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 12.12.2017. |
| 8.12.2017. | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 13.12.2017. |
| 8.12.2017. | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 12.12.2017. |
| 8.12.2017. | Xiapex | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/11/671 | 12.12.2017. |
| 8.12.2017. | Zevalin | Spectrum Pharmaceuticals B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | EU/1/03/264 | 12.12.2017. |
| 11.12.2017. | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | 13.12.2017. |
| 11.12.2017. | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 13.12.2017. |
| 11.12.2017. | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 13.12.2017. |
| 11.12.2017. | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | 13.12.2017. |
| 11.12.2017. | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 15.12.2017. |
| 11.12.2017. | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 13.12.2017. |
| 11.12.2017. | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 13.12.2017. |
| 11.12.2017. | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 13.12.2017. |
| 11.12.2017. | Zyclara | Meda AB
  Pipers väg 2 A, 170 73 Solna, Sverige | EU/1/12/783 | 13.12.2017. |
| 15.12.2017. | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/817 | 19.12.2017. |
| 15.12.2017. | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 19.12.2017. |
| 15.12.2017. | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.12.2017. |
| 15.12.2017. | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 19.12.2017. |
| 15.12.2017. | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.12.2017. |
| 15.12.2017. | M-M-RVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/337 | 19.12.2017. |
| 15.12.2017. | Procysbi | Chiesi Orphan B.V.
  Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland | EU/1/13/861 | 19.12.2017. |
| 15.12.2017. | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 19.12.2017. |
| 15.12.2017. | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 19.12.2017. |
| 15.12.2017. | Stocrin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111 | 19.12.2017. |
| 15.12.2017. | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 19.12.2017. |
| 15.12.2017. | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.12.2017. |
| 18.12.2017. | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 20.12.2017. |
| 18.12.2017. | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 20.12.2017. |
| 18.12.2017. | HBVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/01/183 | 20.12.2017. |
| 18.12.2017. | NovoMix | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/00/142 | 20.12.2017. |
| 18.12.2017. | ProQuad | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/05/323 | 20.12.2017. |
| 18.12.2017. | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 20.12.2017. |
| 20.12.2017. | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 22.12.2017. |
| 20.12.2017. | Duloksetin Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 22.12.2017. |
| 20.12.2017. | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 22.12.2017. |
| 20.12.2017. | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/08/503 | 22.12.2017. |
| 20.12.2017. | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/01/188 | 22.12.2017. |
| 20.12.2017. | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 22.12.2017. |
| 20.12.2017. | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 20.12.2017. |
| 20.12.2017. | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 2.1.2018. |
| 20.12.2017. | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/11/702 | 22.12.2017. |
| 20.12.2017. | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/741 | 22.12.2017. |
| 20.12.2017. | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1108 | 22.12.2017. |
| 20.12.2017. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 22.12.2017. |
| 20.12.2017. | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 22.12.2017. |
| 20.12.2017. | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 22.12.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.12.2017.

Alecensa

Roche Registration Limited

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

EU/1/16/1169

5.12.2017.

1.12.2017.

Hetlioz

Vanda Pharmaceuticals Limited

25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom

EU/1/15/1008

5.12.2017.

1.12.2017.

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

5.12.2017.

1.12.2017.

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

5.12.2017.

1.12.2017.

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.12.2017.

8.12.2017.

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

12.12.2017.

8.12.2017.

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

12.12.2017.

8.12.2017.

Esbriet

Roche Registration Limited

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

EU/1/11/667

13.12.2017.

8.12.2017.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

12.12.2017.

8.12.2017.

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

12.12.2017.

8.12.2017.

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

13.12.2017.

8.12.2017.

Humira

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/03/256

12.12.2017.

8.12.2017.

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

13.12.2017.

8.12.2017.

JETREA

ThromboGenics NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

12.12.2017.

8.12.2017.

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

13.12.2017.

8.12.2017.

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

12.12.2017.

8.12.2017.

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

13.12.2017.

8.12.2017.

Moventig

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/14/962

12.12.2017.

8.12.2017.

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

12.12.2017.

8.12.2017.

Oncaspar

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1070

14.12.2017.

8.12.2017.

Perjeta

Roche Registration Limited

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

EU/1/13/813

13.12.2017.

8.12.2017.

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

12.12.2017.

8.12.2017.

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

12.12.2017.

8.12.2017.

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

13.12.2017.

8.12.2017.

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

12.12.2017.

8.12.2017.

Xiapex

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/11/671

12.12.2017.

8.12.2017.

Zevalin

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/03/264

12.12.2017.

11.12.2017.

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

13.12.2017.

11.12.2017.

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

13.12.2017.

11.12.2017.

Neupro

UCB Pharma S.A.

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

EU/1/05/331

13.12.2017.

11.12.2017.

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

13.12.2017.

11.12.2017.

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

15.12.2017.

11.12.2017.

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

13.12.2017.

11.12.2017.

Strensiq

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/15/1015

13.12.2017.

11.12.2017.

Tarceva

Roche Registration Limited

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

EU/1/05/311

13.12.2017.

11.12.2017.

Zyclara

Meda AB

Pipers väg 2 A, 170 73 Solna, Sverige

EU/1/12/783

13.12.2017.

15.12.2017.

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/817

19.12.2017.

15.12.2017.

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

19.12.2017.

15.12.2017.

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

19.12.2017.

15.12.2017.

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

19.12.2017.

15.12.2017.

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

19.12.2017.

15.12.2017.

M-M-RVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/337

19.12.2017.

15.12.2017.

Procysbi

Chiesi Orphan B.V.

Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland

EU/1/13/861

19.12.2017.

15.12.2017.

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

19.12.2017.

15.12.2017.

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

19.12.2017.

15.12.2017.

Stocrin

Merck Sharp & Dohme Limited

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

EU/1/99/111

19.12.2017.

15.12.2017.

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

19.12.2017.

15.12.2017.

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

19.12.2017.

18.12.2017.

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

20.12.2017.

18.12.2017.

Enbrel

Pfizer Limited

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

EU/1/99/126

20.12.2017.

18.12.2017.

HBVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/01/183

20.12.2017.

18.12.2017.

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

20.12.2017.

18.12.2017.

ProQuad

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/05/323

20.12.2017.

18.12.2017.

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

20.12.2017.

20.12.2017.

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

22.12.2017.

20.12.2017.

Duloksetin Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

22.12.2017.

20.12.2017.

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

22.12.2017.

20.12.2017.

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

22.12.2017.

20.12.2017.

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/01/188

22.12.2017.

20.12.2017.

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

22.12.2017.

20.12.2017.

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

20.12.2017.

20.12.2017.

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

2.1.2018.

20.12.2017.

Levetiracetam ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/702

22.12.2017.

20.12.2017.

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/741

22.12.2017.

20.12.2017.

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.12.2017.

20.12.2017.

Ranexa

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462

22.12.2017.

20.12.2017.

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

22.12.2017.

20.12.2017.

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

22.12.2017.

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.12.2017. | Rabitec | Cjepivo protiv bjesnoće (živo, oralno) za lisice i kunopse | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | Peroralna suspenzija | QI07BD | 5.12.2017. |

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

1.12.2017.

Rabitec

Cjepivo protiv bjesnoće (živo, oralno) za lisice i kunopse

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

Peroralna suspenzija

QI07BD

5.12.2017.

—   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 |
| --- | --- | --- | --- | --- |
| 6.12.2017. | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 8.12.2017. |
| 6.12.2017. | Spironolactone Ceva | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/07/074 | 8.12.2017. |
| 18.12.2017. | Sedadex | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/16/198 | 20.12.2017. |
| 20.12.2017. | Easotic | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France | EU/2/08/085 | 22.12.2017. |
| 20.12.2017. | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros Cedex, France | EU/2/09/096 | 22.12.2017. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.12.2017.

Kexxtone

Eli Lilly and Company Limited

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

EU/2/12/145

8.12.2017.

6.12.2017.

Spironolactone Ceva

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/07/074

8.12.2017.

18.12.2017.

Sedadex

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/16/198

20.12.2017.

20.12.2017.

Easotic

VIRBAC S.A.

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

EU/2/08/085

22.12.2017.

20.12.2017.

Leucogen

Virbac

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

EU/2/09/096

22.12.2017.

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---

| 26.1.2018 | HR | Službeni list Europske unije | C 30/10 |
| --- | --- | --- | --- |

26.1.2018

HR

Službeni list Europske unije

C 30/10

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2017. do 31. prosinca 2017.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

(2018/C 030/02)

—   Odbijanje nacionalnog odobrenja za stavljanje u promet

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 18.12.2017. | Alcover and associated names – Art 29 | Sodium oxybate | — | — | 19.12.2017. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

18.12.2017.

Alcover and associated names – Art 29

Sodium oxybate

—

—

19.12.2017.

---

(1)  SL L 311, 28.11.2001., str. 67.

(2)  SL L 311, 28.11.2001., str. 1.

---