# Uradni list C 439/30.

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 439 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5830. december 2015 |

ISSN 1977-1045

Uradni list

Evropske unije

C 439

Slovenska izdaja

Informacije in objave

Zvezek 5830. december 2015

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2015/C 439/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2015/C 439/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 12 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2015/C 439/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015(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

2015/C 439/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015(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)

12

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

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 30.12.2015 | SL | Uradni list Evropske unije | C 439/1 |
| --- | --- | --- | --- |

30.12.2015

SL

Uradni list Evropske unije

C 439/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015

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

(2015/C 439/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.11.2015 | Edistride | dapagliflozin | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1052 | Filmsko obložene tablete | A10BX09 | 12.11.2015 |
| 11.11.2015 | Obizur | Susoktokog alfa | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | EU/1/15/1035 | Prašek in vehikel za raztopino za injiciranje | B02BD14 | 13.11.2015 |
| 16.11.2015 | Aripiprazole Accord | aripiprazol | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1045 | Tableta | N05AX12 | 19.11.2015 |
| 16.11.2015 | Ebymect | dapagliflozin/metforminijevega | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1051 | Filmsko obložene tablete | A10BD15 | 18.11.2015 |
| 16.11.2015 | Votubia | Everolimus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | Tableta | L01XE10 | 23.11.2015 |
| 19.11.2015 | Cinacalcet Mylan | cinakalcet | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1054 | Filmsko obložene tablete | H05BX01 | 23.11.2015 |
| 19.11.2015 | Elocta | efmoroktokog alfa (efmoroctocogum alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/15/1046 | Prašek in vehikel za raztopino za injiciranje | Pending | 23.11.2015 |
| 19.11.2015 | Entresto | sakubitril/valsartan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | Filmsko obložene tablete | C09DX04 | 23.11.2015 |
| 19.11.2015 | Genvoya | elvitegravir/cobicistat/emtricitabină/tenofovir alafenamidă | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | Filmsko obložene tablete | J05AR18 | 23.11.2015 |
| 19.11.2015 | IONSYS | fentanil | Incline Therapeutics Europe Ltd
  21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom | EU/1/15/1050 | Transdermalni sistem | N02AB03 | 23.11.2015 |
| 19.11.2015 | Kyprolis | karfilzomib | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | Prašek za raztopino za infundiranje | L01XX45 | 23.11.2015 |
| 19.11.2015 | Numient | levodope/karbidope | Impax Laboratories (Netherlands) BV
  WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland | EU/1/15/1044 | Kapsula s prirejenim sproščanjem, trda | N04BA02 | 23.11.2015 |
| 19.11.2015 | Orkambi | Lumakaftor/ivakaftor | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | Filmsko obložene tablete | R07AX30 | 24.11.2015 |
| 20.11.2015 | Cotellic | kobimetinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | Filmsko obložene tablete | Pending | 24.11.2015 |
| 20.11.2015 | Kolbam | holna kislina | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | EU/1/13/895 | Kapsula, trda | A05AA03 | 24.11.2015 |
| 20.11.2015 | Pemetrexed Hospira | pemetreksed | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/15/1057 | Prašek za koncentrat za raztopino za infundiranje | L01BA04 | 24.11.2015 |
| 20.11.2015 | Praxbind | idarucizumab | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | prašek in vehikel za raztopino za injiciranje/infundiranje | V03AB | 24.11.2015 |
| 23.11.2015 | Blincyto | blinatumomab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | Prašek za koncentrat za raztopino za infundiranje | L01XC19 | 25.11.2015 |
| 27.11.2015 | Pemetrexed medac | pemetreksed | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/15/1038 | Prašek za koncentrat za raztopino za infundiranje | L01BA04 | 1.12.2015 |
| 27.11.2015 | Ravicti | Glicerol fenilbutirat | Horizon Therapeutics Limited
  90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom | EU/1/15/1062 | Peroralna tekočina | A16AX09 | 1.12.2015 |

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

9.11.2015

Edistride

dapagliflozin

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1052

Filmsko obložene tablete

A10BX09

12.11.2015

11.11.2015

Obizur

Susoktokog alfa

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

EU/1/15/1035

Prašek in vehikel za raztopino za injiciranje

B02BD14

13.11.2015

16.11.2015

Aripiprazole Accord

aripiprazol

Accord Healthcare Limited

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

EU/1/15/1045

Tableta

N05AX12

19.11.2015

16.11.2015

Ebymect

dapagliflozin/metforminijevega

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1051

Filmsko obložene tablete

A10BD15

18.11.2015

16.11.2015

Votubia

Everolimus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

Tableta

L01XE10

23.11.2015

19.11.2015

Cinacalcet Mylan

cinakalcet

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/15/1054

Filmsko obložene tablete

H05BX01

23.11.2015

19.11.2015

Elocta

efmoroktokog alfa (efmoroctocogum alfa)

Biogen Idec Limited

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

EU/1/15/1046

Prašek in vehikel za raztopino za injiciranje

Pending

23.11.2015

19.11.2015

Entresto

sakubitril/valsartan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

Filmsko obložene tablete

C09DX04

23.11.2015

19.11.2015

Genvoya

elvitegravir/cobicistat/emtricitabină/tenofovir alafenamidă

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

Filmsko obložene tablete

J05AR18

23.11.2015

19.11.2015

IONSYS

fentanil

Incline Therapeutics Europe Ltd

21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom

EU/1/15/1050

Transdermalni sistem

N02AB03

23.11.2015

19.11.2015

Kyprolis

karfilzomib

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

Prašek za raztopino za infundiranje

L01XX45

23.11.2015

19.11.2015

Numient

levodope/karbidope

Impax Laboratories (Netherlands) BV

WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland

EU/1/15/1044

Kapsula s prirejenim sproščanjem, trda

N04BA02

23.11.2015

19.11.2015

Orkambi

Lumakaftor/ivakaftor

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

Filmsko obložene tablete

R07AX30

24.11.2015

20.11.2015

Cotellic

kobimetinib

Roche Registration Limited

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

EU/1/15/1048

Filmsko obložene tablete

Pending

24.11.2015

20.11.2015

Kolbam

holna kislina

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

EU/1/13/895

Kapsula, trda

A05AA03

24.11.2015

20.11.2015

Pemetrexed Hospira

pemetreksed

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/15/1057

Prašek za koncentrat za raztopino za infundiranje

L01BA04

24.11.2015

20.11.2015

Praxbind

idarucizumab

Boehringer Ingelheim International GmbH

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

EU/1/15/1056

prašek in vehikel za raztopino za injiciranje/infundiranje

V03AB

24.11.2015

23.11.2015

Blincyto

blinatumomab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

Prašek za koncentrat za raztopino za infundiranje

L01XC19

25.11.2015

27.11.2015

Pemetrexed medac

pemetreksed

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/15/1038

Prašek za koncentrat za raztopino za infundiranje

L01BA04

1.12.2015

27.11.2015

Ravicti

Glicerol fenilbutirat

Horizon Therapeutics Limited

90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom

EU/1/15/1062

Peroralna tekočina

A16AX09

1.12.2015

—   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 |
| --- | --- | --- | --- | --- |
| 3.11.2015 | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/718 | 5.11.2015 |
| 3.11.2015 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 5.11.2015 |
| 6.11.2015 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 10.11.2015 |
| 6.11.2015 | Vedrop | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/09/533 | 10.11.2015 |
| 10.11.2015 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 12.11.2015 |
| 11.11.2015 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185 | 13.11.2015 |
| 11.11.2015 | Comtan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/081 | 13.11.2015 |
| 11.11.2015 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 13.11.2015 |
| 11.11.2015 | Revestive | NPS Pharma Holdings Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 13.11.2015 |
| 11.11.2015 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 13.11.2015 |
| 16.11.2015 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 18.11.2015 |
| 16.11.2015 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 19.11.2015 |
| 16.11.2015 | Suboxone | Indivior UK Limited
  103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom | EU/1/06/359 | 18.11.2015 |
| 19.11.2015 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 23.11.2015 |
| 19.11.2015 | Alimta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/290 | 23.11.2015 |
| 19.11.2015 | Carbaglu | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/02/246 | 23.11.2015 |
| 19.11.2015 | Colobreathe | Forest Laboratories UK Ltd.
  Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom | EU/1/11/747 | 23.11.2015 |
| 19.11.2015 | Cosentyx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/980 | 23.11.2015 |
| 19.11.2015 | Cubicin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/328 | 23.11.2015 |
| 19.11.2015 | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/06/379 | 23.11.2015 |
| 19.11.2015 | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 23.11.2015 |
| 19.11.2015 | Exelon | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/066 | 23.11.2015 |
| 19.11.2015 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 23.11.2015 |
| 19.11.2015 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 23.11.2015 |
| 19.11.2015 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 23.11.2015 |
| 19.11.2015 | Ifirmacombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 23.11.2015 |
| 19.11.2015 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 23.11.2015 |
| 19.11.2015 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 23.11.2015 |
| 19.11.2015 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 23.11.2015 |
| 19.11.2015 | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 23.11.2015 |
| 19.11.2015 | Lamivudine/Zidovudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/663 | 23.11.2015 |
| 19.11.2015 | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/05/325 | 24.11.2015 |
| 19.11.2015 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 23.11.2015 |
| 19.11.2015 | NovoNorm | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/98/076 | 23.11.2015 |
| 19.11.2015 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 23.11.2015 |
| 19.11.2015 | Prandin | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/162 | 23.11.2015 |
| 19.11.2015 | Prometax | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/092 | 23.11.2015 |
| 19.11.2015 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 23.11.2015 |
| 19.11.2015 | Simulect | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/084 | 23.11.2015 |
| 19.11.2015 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | EU/1/11/669 | 23.11.2015 |
| 19.11.2015 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 23.11.2015 |
| 19.11.2015 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 23.11.2015 |
| 19.11.2015 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/08/499 | 23.11.2015 |
| 19.11.2015 | Vfend | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/212 | 23.11.2015 |
| 19.11.2015 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 23.11.2015 |
| 19.11.2015 | Xenical | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/071 | 23.11.2015 |
| 20.11.2015 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 24.11.2015 |
| 20.11.2015 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 25.11.2015 |
| 23.11.2015 | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 25.11.2015 |
| 23.11.2015 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 25.11.2015 |
| 23.11.2015 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 25.11.2015 |
| 23.11.2015 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 25.11.2015 |
| 23.11.2015 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 25.11.2015 |
| 27.11.2015 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 1.12.2015 |
| 27.11.2015 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 1.12.2015 |
| 27.11.2015 | Pandemic influenza vaccine H5N1 BAXTER | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/09/571 | 1.12.2015 |
| 27.11.2015 | Quinsair | Raptor Pharmaceuticals Europe BV
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/14/973 | 1.12.2015 |
| 27.11.2015 | Rapamune | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/01/171 | 2.12.2015 |
| 27.11.2015 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 1.12.2015 |
| 27.11.2015 | Rivastigmine HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/09/589 | 30.11.2015 |
| 27.11.2015 | Rivastigmine Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/09/599 | 2.12.2015 |
| 27.11.2015 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 1.12.2015 |
| 30.11.2015 | Celvapan | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/08/506 | 2.12.2015 |
| 30.11.2015 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH
  Keltenring 1 + 3, D-82041 Oberhaching, Deutschland | EU/1/09/585 | 2.12.2015 |
| 30.11.2015 | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/12/752 | 2.12.2015 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.11.2015

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/718

5.11.2015

3.11.2015

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

5.11.2015

6.11.2015

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

10.11.2015

6.11.2015

Vedrop

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/09/533

10.11.2015

10.11.2015

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

12.11.2015

11.11.2015

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

13.11.2015

11.11.2015

Comtan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/081

13.11.2015

11.11.2015

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

13.11.2015

11.11.2015

Revestive

NPS Pharma Holdings Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

13.11.2015

11.11.2015

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

13.11.2015

16.11.2015

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

18.11.2015

16.11.2015

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

19.11.2015

16.11.2015

Suboxone

Indivior UK Limited

103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom

EU/1/06/359

18.11.2015

19.11.2015

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

23.11.2015

19.11.2015

Alimta

Eli Lilly Nederland B.V.

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

EU/1/04/290

23.11.2015

19.11.2015

Carbaglu

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/02/246

23.11.2015

19.11.2015

Colobreathe

Forest Laboratories UK Ltd.

Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom

EU/1/11/747

23.11.2015

19.11.2015

Cosentyx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/980

23.11.2015

19.11.2015

Cubicin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/328

23.11.2015

19.11.2015

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/06/379

23.11.2015

19.11.2015

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

23.11.2015

19.11.2015

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/066

23.11.2015

19.11.2015

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

23.11.2015

19.11.2015

HALAVEN

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/11/678

23.11.2015

19.11.2015

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

23.11.2015

19.11.2015

Ifirmacombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

23.11.2015

19.11.2015

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

23.11.2015

19.11.2015

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

23.11.2015

19.11.2015

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

23.11.2015

19.11.2015

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

23.11.2015

19.11.2015

Lamivudine/Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

23.11.2015

19.11.2015

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/05/325

24.11.2015

19.11.2015

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

23.11.2015

19.11.2015

NovoNorm

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/98/076

23.11.2015

19.11.2015

Optimark

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland

EU/1/07/398

23.11.2015

19.11.2015

Prandin

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/162

23.11.2015

19.11.2015

Prometax

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/092

23.11.2015

19.11.2015

Ranexa

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462

23.11.2015

19.11.2015

Simulect

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/084

23.11.2015

19.11.2015

Teysuno

Nordic Group B.V.

Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland

EU/1/11/669

23.11.2015

19.11.2015

Thalidomide Celgene

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

23.11.2015

19.11.2015

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

23.11.2015

19.11.2015

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/08/499

23.11.2015

19.11.2015

Vfend

Pfizer Limited

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

EU/1/02/212

23.11.2015

19.11.2015

XALKORI

Pfizer Limited

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

EU/1/12/793

23.11.2015

19.11.2015

Xenical

Roche Registration Limited

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

EU/1/98/071

23.11.2015

20.11.2015

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

24.11.2015

20.11.2015

Volibris

Glaxo Group Ltd

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

EU/1/08/451

25.11.2015

23.11.2015

alli

Glaxo Group Ltd

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

EU/1/07/401

25.11.2015

23.11.2015

Bosulif

Pfizer Limited

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

EU/1/13/818

25.11.2015

23.11.2015

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

25.11.2015

23.11.2015

XALKORI

Pfizer Limited

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

EU/1/12/793

25.11.2015

23.11.2015

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

25.11.2015

27.11.2015

CellCept

Roche Registration Limited

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

EU/1/96/005

1.12.2015

27.11.2015

Iclusig

ARIAD Pharma Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

1.12.2015

27.11.2015

Pandemic influenza vaccine H5N1 BAXTER

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/09/571

1.12.2015

27.11.2015

Quinsair

Raptor Pharmaceuticals Europe BV

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/14/973

1.12.2015

27.11.2015

Rapamune

Pfizer Limited

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

EU/1/01/171

2.12.2015

27.11.2015

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

1.12.2015

27.11.2015

Rivastigmine HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

30.11.2015

27.11.2015

Rivastigmine Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/09/599

2.12.2015

27.11.2015

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

1.12.2015

30.11.2015

Celvapan

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/08/506

2.12.2015

30.11.2015

Rivastigmine 1 A Pharma

1 A Pharma GmbH

Keltenring 1 + 3, D-82041 Oberhaching, Deutschland

EU/1/09/585

2.12.2015

30.11.2015

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/12/752

2.12.2015

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

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 30.11.2015 | Nivolumab BMS | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1026 | 2.12.2015 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

30.11.2015

Nivolumab BMS

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1026

2.12.2015

—   Umik dovoljenja za promet (člen 20 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 20.11.2015 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 24.11.2015 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

20.11.2015

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

24.11.2015

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.11.2015 | Simparica | sarolaner | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | Žvečljive tablete | QP53BX06 | 10.11.2015 |
| 6.11.2015 | Suvaxyn Circo + MH RTU | Inaktivirano cepivo proti prašičjemu cirkovirusu in prašičji enzootski pnevmoniji. | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/190 | emulzija za injiciranje | QI09AL | 10.11.2015 |
| 6.11.2015 | Zycortal | dezoksikorton | Dechra Limited
  Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom | EU/2/15/189 | Suspenzija za injiciranje | QH02AA03 | 10.11.2015 |

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

6.11.2015

Simparica

sarolaner

Zoetis Belgium S.A.

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

EU/2/15/191

Žvečljive tablete

QP53BX06

10.11.2015

6.11.2015

Suvaxyn Circo + MH RTU

Inaktivirano cepivo proti prašičjemu cirkovirusu in prašičji enzootski pnevmoniji.

Zoetis Belgium S.A.

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

EU/2/15/190

emulzija za injiciranje

QI09AL

10.11.2015

6.11.2015

Zycortal

dezoksikorton

Dechra Limited

Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom

EU/2/15/189

Suspenzija za injiciranje

QH02AA03

10.11.2015

—   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 |
| --- | --- | --- | --- | --- |
| 6.11.2015 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/10/114 | 10.11.2015 |
| 9.11.2015 | Nobivac Bb | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/02/034 | 11.11.2015 |
| 19.11.2015 | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | EU/2/09/101 | 23.11.2015 |
| 20.11.2015 | Leucofeligen FeLV/RCP | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/09/097 | 24.11.2015 |
| 27.11.2015 | Leucogen | Virbac
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/09/096 | 1.12.2015 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.11.2015

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/10/114

10.11.2015

9.11.2015

Nobivac Bb

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/02/034

11.11.2015

19.11.2015

Zolvix

Novartis Healthcare A/S

Edvard Thomsens Vej 14, DK-2300 København S, Danmark

EU/2/09/101

23.11.2015

20.11.2015

Leucofeligen FeLV/RCP

Virbac

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

EU/2/09/097

24.11.2015

27.11.2015

Leucogen

Virbac

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

EU/2/09/096

1.12.2015

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

| 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

---

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

---

| 30.12.2015 | SL | Uradni list Evropske unije | C 439/12 |
| --- | --- | --- | --- |

30.12.2015

SL

Uradni list Evropske unije

C 439/12

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. novembra 2015 do 30. novembra 2015

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

(2015/C 439/02)

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- | --- |
| 27.11.2015 | Repaglinide | repaglinide | Ni relevantno | Ni relevantno | 30.11.2015 |
| 23.11.2015 | Orlistat | Orlistat | Ni relevantno | Ni relevantno | 24.11.2015 |
| 20.11.2015 | Rivastigmine | Rivastigmine | Ni relevantno | Ni relevantno | 24.11.2015 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

27.11.2015

Repaglinide

repaglinide

Ni relevantno

Ni relevantno

30.11.2015

23.11.2015

Orlistat

Orlistat

Ni relevantno

Ni relevantno

24.11.2015

20.11.2015

Rivastigmine

Rivastigmine

Ni relevantno

Ni relevantno

24.11.2015

---

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

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

---