# Uradni list C 30/26.

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 30 |
| | |
| Slovenska izdaja | Informacije in objave | Letnik 6126. januar 2018 |

ISSN 1977-1045

Uradni list

Evropske unije

C 30

Slovenska izdaja

Informacije in objave

Letnik 6126. januar 2018

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2018/C 30/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2018/C 30/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 10 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2018/C 30/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

2018/C 30/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

10

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| SL | |
| --- | --- |

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 26.1.2018 | SL | Uradni list Evropske unije | C 30/1 |
| --- | --- | --- | --- |

26.1.2018

SL

Uradni list Evropske unije

C 30/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))

(2018/C 030/01)

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.12.2017 | Tacforius | takrolimus | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | Trda kapsula s podaljšanim sproščanjem | 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, trda | L01XE36 | 20.12.2017 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

8.12.2017

Tacforius

takrolimus

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

Trda kapsula s podaljšanim sproščanjem

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, trda

L01XE36

20.12.2017

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Zavrnjena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 Paris, France | — | 20.12.2017 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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 Paris, France

—

20.12.2017

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 2A, 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 | Duloxetine 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 sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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 2A, 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

Duloxetine 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

—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.12.2017 | Rabitec | Cepivo za steklino (živo, peroralno) za lisice in rakunaste pse | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | Oralna suspenzija | QI07BD | 5.12.2017 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

1.12.2017

Rabitec

Cepivo za steklino (živo, peroralno) za lisice in rakunaste pse

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

Oralna suspenzija

QI07BD

5.12.2017

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| 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)  UL L 136, 30.4.2004, str. 1.

---

| 26.1.2018 | SL | Uradni list Evropske unije | C 30/10 |
| --- | --- | --- | --- |

26.1.2018

SL

Uradni list Evropske unije

C 30/10

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. decembra 2017 do 31. decembra 2017

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES (1) ali člena 38 Direktive 2001/82/ES (2))

(2018/C 030/02)

—   Zavrnitev izdaje nacionalnega dovoljenja za promet z zdravili

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- | --- |
| 18.12.2017 | Alcover and associated names – Art 29 | Sodium oxybate | — | — | 19.12.2017 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

18.12.2017

Alcover and associated names – Art 29

Sodium oxybate

—

—

19.12.2017

---

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

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

---