# Den Europæiske Unions C 439/30.

| | ISSN 1977-0871 |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 439 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 58. årgang30. december 2015 |

ISSN 1977-0871

Den Europæiske Unions

Tidende

C 439

Dansk udgave

Meddelelser og oplysninger

58. årgang30. december 2015

---

| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2015/C 439/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2015/C 439/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF) | 12 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2015/C 439/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

1

2015/C 439/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF eller artikel 38 i direktiv 2001/82/EF)

12

---

| DA | |
| --- | --- |

DA

---

IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 30.12.2015 | DA | Den Europæiske Unions Tidende | C 439/1 |
| --- | --- | --- | --- |

30.12.2015

DA

Den Europæiske Unions Tidende

C 439/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004 (1))

(2015/C 439/01)

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.11.2015 | Edistride | dapagliflozin | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1052 | Filmovertrukket tablet | A10BX09 | 12.11.2015 |
| 11.11.2015 | Obizur | Susoctocog alfa | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Vienna, Österreich | EU/1/15/1035 | Pulver og solvens til opløsning, injektion | 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 | Tablet | N05AX12 | 19.11.2015 |
| 16.11.2015 | Ebymect | dapagliflozin/metformin | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1051 | Filmovertrukket tablet | A10BD15 | 18.11.2015 |
| 16.11.2015 | Votubia | Everolimus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | Tablet | L01XE10 | 23.11.2015 |
| 19.11.2015 | Cinacalcet Mylan | cinacalcet | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/15/1054 | Filmovertrukket tablet | H05BX01 | 23.11.2015 |
| 19.11.2015 | Elocta | efmoroctocog alfa | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/15/1046 | Pulver og solvens til opløsning, injektion | Pending | 23.11.2015 |
| 19.11.2015 | Entresto | sacubitril/valsartan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | Filmovertrukket tablet | C09DX04 | 23.11.2015 |
| 19.11.2015 | Genvoya | elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | Filmovertrukket tablet | J05AR18 | 23.11.2015 |
| 19.11.2015 | IONSYS | fentanyl | Incline Therapeutics Europe Ltd
  21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom | EU/1/15/1050 | Transdermalt system | N02AB03 | 23.11.2015 |
| 19.11.2015 | Kyprolis | carfilzomib | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | Pulver til infusionsvæske, opløsning | L01XX45 | 23.11.2015 |
| 19.11.2015 | Numient | levodopa/carbidopa | Impax Laboratories (Netherlands) BV
  WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland | EU/1/15/1044 | Kapsel med modificeret udløsning, hård | N04BA02 | 23.11.2015 |
| 19.11.2015 | Orkambi | Lumacaftor/ivacaftor | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | Filmovertrukket tablet | R07AX30 | 24.11.2015 |
| 20.11.2015 | Cotellic | cobimetinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | Filmovertrukket tablet | Pending | 24.11.2015 |
| 20.11.2015 | Kolbam | Cholsyre | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | EU/1/13/895 | Kapsler, hårde | A05AA03 | 24.11.2015 |
| 20.11.2015 | Pemetrexed Hospira | pemetrexed | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/15/1057 | Pulver til koncentrat til infusionsvæske, opløsning | 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 | Pulver og solvens til injektions-/infusionsvæske, opløsning | V03AB | 24.11.2015 |
| 23.11.2015 | Blincyto | blinatumomab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | Pulver til koncentrat til infusionsvæske, opløsning | L01XC19 | 25.11.2015 |
| 27.11.2015 | Pemetrexed medac | Pemetrexed | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/15/1038 | Pulver til koncentrat til infusionsvæske, opløsning | L01BA04 | 1.12.2015 |
| 27.11.2015 | Ravicti | Glycerolphenylbutyrat | Horizon Therapeutics Limited
  90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom | EU/1/15/1062 | Oral væske | A16AX09 | 1.12.2015 |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

9.11.2015

Edistride

dapagliflozin

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1052

Filmovertrukket tablet

A10BX09

12.11.2015

11.11.2015

Obizur

Susoctocog alfa

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna, Österreich

EU/1/15/1035

Pulver og solvens til opløsning, injektion

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

Tablet

N05AX12

19.11.2015

16.11.2015

Ebymect

dapagliflozin/metformin

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1051

Filmovertrukket tablet

A10BD15

18.11.2015

16.11.2015

Votubia

Everolimus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

Tablet

L01XE10

23.11.2015

19.11.2015

Cinacalcet Mylan

cinacalcet

Mylan S.A.S

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

EU/1/15/1054

Filmovertrukket tablet

H05BX01

23.11.2015

19.11.2015

Elocta

efmoroctocog alfa

Biogen Idec Limited

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

EU/1/15/1046

Pulver og solvens til opløsning, injektion

Pending

23.11.2015

19.11.2015

Entresto

sacubitril/valsartan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

Filmovertrukket tablet

C09DX04

23.11.2015

19.11.2015

Genvoya

elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

Filmovertrukket tablet

J05AR18

23.11.2015

19.11.2015

IONSYS

fentanyl

Incline Therapeutics Europe Ltd

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

EU/1/15/1050

Transdermalt system

N02AB03

23.11.2015

19.11.2015

Kyprolis

carfilzomib

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

Pulver til infusionsvæske, opløsning

L01XX45

23.11.2015

19.11.2015

Numient

levodopa/carbidopa

Impax Laboratories (Netherlands) BV

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

EU/1/15/1044

Kapsel med modificeret udløsning, hård

N04BA02

23.11.2015

19.11.2015

Orkambi

Lumacaftor/ivacaftor

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

Filmovertrukket tablet

R07AX30

24.11.2015

20.11.2015

Cotellic

cobimetinib

Roche Registration Limited

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

EU/1/15/1048

Filmovertrukket tablet

Pending

24.11.2015

20.11.2015

Kolbam

Cholsyre

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

EU/1/13/895

Kapsler, hårde

A05AA03

24.11.2015

20.11.2015

Pemetrexed Hospira

pemetrexed

Hospira UK Limited

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

EU/1/15/1057

Pulver til koncentrat til infusionsvæske, opløsning

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

Pulver og solvens til injektions-/infusionsvæske, opløsning

V03AB

24.11.2015

23.11.2015

Blincyto

blinatumomab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

Pulver til koncentrat til infusionsvæske, opløsning

L01XC19

25.11.2015

27.11.2015

Pemetrexed medac

Pemetrexed

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/15/1038

Pulver til koncentrat til infusionsvæske, opløsning

L01BA04

1.12.2015

27.11.2015

Ravicti

Glycerolphenylbutyrat

Horizon Therapeutics Limited

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

EU/1/15/1062

Oral væske

A16AX09

1.12.2015

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Tilbagekaldelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Suspension af markedsføringstilladelse (artikel 20 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 20.11.2015 | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland | EU/1/02/226 | 24.11.2015 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

20.11.2015

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland

EU/1/02/226

24.11.2015

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.11.2015 | Simparica | sarolaner | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | Tyggetabletter | QP53BX06 | 10.11.2015 |
| 6.11.2015 | Suvaxyn Circo + MH RTU | Vaccine mod porcint circovirus og enzootisk pneumoni (inaktiveret) | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/190 | Injektionsvœske, emulsion | QI09AL | 10.11.2015 |
| 6.11.2015 | Zycortal | desoxycorton | Dechra Limited
  Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom | EU/2/15/189 | Suspension til injektion | QH02AA03 | 10.11.2015 |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

6.11.2015

Simparica

sarolaner

Zoetis Belgium S.A.

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

EU/2/15/191

Tyggetabletter

QP53BX06

10.11.2015

6.11.2015

Suvaxyn Circo + MH RTU

Vaccine mod porcint circovirus og enzootisk pneumoni (inaktiveret)

Zoetis Belgium S.A.

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

EU/2/15/190

Injektionsvœske, emulsion

QI09AL

10.11.2015

6.11.2015

Zycortal

desoxycorton

Dechra Limited

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

EU/2/15/189

Suspension til injektion

QH02AA03

10.11.2015

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.04, s. 1.

---

| 30.12.2015 | DA | Den Europæiske Unions Tidende | C 439/12 |
| --- | --- | --- | --- |

30.12.2015

DA

Den Europæiske Unions Tidende

C 439/12

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. november 2015 til 30. november 2015

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF (1) eller artikel 38 i direktiv 2001/82/EF (2))

(2015/C 439/02)

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | INN-navn (International Non-Proprietary Name) | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- | --- |
| 27.11.2015 | Repaglinide | repaglinide | Ikke relevant | Ikke relevant | 30.11.2015 |
| 23.11.2015 | Orlistat | Orlistat | Ikke relevant | Ikke relevant | 24.11.2015 |
| 20.11.2015 | Rivastigmine | Rivastigmine | Ikke relevant | Ikke relevant | 24.11.2015 |

Dato for afgørelser

Lægemidlets navn/navne

INN-navn (International Non-Proprietary Name)

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

27.11.2015

Repaglinide

repaglinide

Ikke relevant

Ikke relevant

30.11.2015

23.11.2015

Orlistat

Orlistat

Ikke relevant

Ikke relevant

24.11.2015

20.11.2015

Rivastigmine

Rivastigmine

Ikke relevant

Ikke relevant

24.11.2015

---

(1)  EUT L 311 af 28.11.01, s. 67.

(2)  EUT L 311 af 28.11.01, s. 1.

---