# Uradni list C 116/1. a

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 116 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 591. april 2016 |

ISSN 1977-1045

Uradni list

Evropske unije

C 116

Slovenska izdaja

Informacije in objave

Zvezek 591. april 2016

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2016/C 116/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. februarja 2016 do 29. februarja 2016(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2016/C 116/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. februarja 2016 do 29. februarja 2016(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

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

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 1.4.2016 | SL | Uradni list Evropske unije | C 116/1 |
| --- | --- | --- | --- |

1.4.2016

SL

Uradni list Evropske unije

C 116/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. februarja 2016 do 29. februarja 2016

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

(2016/C 116/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.2.2016 | TAGRISSO | osimertinib | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1086 | Filmsko obložene tablete | L01XE35 | 4.2.2016 |
| 11.2.2016 | Caspofungin Accord | kaspofungin | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1081 | Prašek za koncentrat za raztopino za infundiranje | J02AX04 | 15.2.2016 |
| 15.2.2016 | Portrazza | necitumumab | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/15/1084 | Koncentrat za raztopino za infundiranje | L01XC22 | 18.2.2016 |
| 15.2.2016 | Vaxelis | Konjugirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu tipa b (adsorbirano) | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1079 | Suspenzija za injiciranje | J07CA09 | 17.2.2016 |
| 18.2.2016 | Feraccru | železov maltol | Iron Therapeutics (UK) Ltd
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | Kapsula, trda | B03AB10 | 22.2.2016 |
| 18.2.2016 | Iblias | oktokog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1077 | Prašek in vehikel za raztopino za injiciranje | B02BD02 | 22.2.2016 |
| 18.2.2016 | Kovaltry | oktokog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1076 | Prašek in vehikel za raztopino za injiciranje | B02BD02 | 22.2.2016 |
| 18.2.2016 | Zurampic | lesinurad | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1080 | Filmsko obložene tablete | M04AB05 | 22.2.2016 |

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

2.2.2016

TAGRISSO

osimertinib

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1086

Filmsko obložene tablete

L01XE35

4.2.2016

11.2.2016

Caspofungin Accord

kaspofungin

Accord Healthcare Limited

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

EU/1/15/1081

Prašek za koncentrat za raztopino za infundiranje

J02AX04

15.2.2016

15.2.2016

Portrazza

necitumumab

Eli Lilly Nederland B.V.

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

EU/1/15/1084

Koncentrat za raztopino za infundiranje

L01XC22

18.2.2016

15.2.2016

Vaxelis

Konjugirano cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rekombinantno), otroški paralizi (inaktivirano) in hemofilusu tipa b (adsorbirano)

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1079

Suspenzija za injiciranje

J07CA09

17.2.2016

18.2.2016

Feraccru

železov maltol

Iron Therapeutics (UK) Ltd

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

Kapsula, trda

B03AB10

22.2.2016

18.2.2016

Iblias

oktokog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1077

Prašek in vehikel za raztopino za injiciranje

B02BD02

22.2.2016

18.2.2016

Kovaltry

oktokog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1076

Prašek in vehikel za raztopino za injiciranje

B02BD02

22.2.2016

18.2.2016

Zurampic

lesinurad

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1080

Filmsko obložene tablete

M04AB05

22.2.2016

—   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 |
| --- | --- | --- | --- | --- |
| 8.2.2016 | Hepsera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/251 | 10.2.2016 |
| 8.2.2016 | Irbesartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/576 | 10.2.2016 |
| 8.2.2016 | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/070 | 10.2.2016 |
| 8.2.2016 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 10.2.2016 |
| 8.2.2016 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/069 | 10.2.2016 |
| 8.2.2016 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 10.2.2016 |
| 11.2.2016 | Sevelamer carbonate Zentiva | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/952 | 15.2.2016 |
| 11.2.2016 | Simbrinza | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | 15.2.2016 |
| 11.2.2016 | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 15.2.2016 |
| 11.2.2016 | Truvada | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/04/305 | 15.2.2016 |
| 11.2.2016 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/883 | 15.2.2016 |
| 11.2.2016 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 15.2.2016 |
| 11.2.2016 | Zoledronska kislina Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/771 | 15.2.2016 |
| 11.2.2016 | Zostavax | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/341 | 15.2.2016 |
| 11.2.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 15.2.2016 |
| 15.2.2016 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom | EU/1/14/913 | 17.2.2016 |
| 15.2.2016 | Rivastigmine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/693 | 17.2.2016 |
| 18.2.2016 | Aldara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/98/080 | 22.2.2016 |
| 18.2.2016 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/700 | 22.2.2016 |
| 18.2.2016 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 22.2.2016 |
| 18.2.2016 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 22.2.2016 |
| 18.2.2016 | BYDUREON | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/696 | 22.2.2016 |
| 18.2.2016 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/11/687 | 22.2.2016 |
| 18.2.2016 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 22.2.2016 |
| 18.2.2016 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 22.2.2016 |
| 18.2.2016 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 22.2.2016 |
| 18.2.2016 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 22.2.2016 |
| 18.2.2016 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 22.2.2016 |
| 18.2.2016 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 22.2.2016 |
| 18.2.2016 | TOBI Podhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/652 | 22.2.2016 |
| 18.2.2016 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 22.2.2016 |
| 18.2.2016 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 22.2.2016 |
| 22.2.2016 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 24.2.2016 |
| 22.2.2016 | Constella | Allergan Pharmaceuticals International Ltd.
  Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland | EU/1/12/801 | 24.2.2016 |
| 22.2.2016 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 24.2.2016 |
| 22.2.2016 | Fasturtec | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/00/170 | 24.2.2016 |
| 22.2.2016 | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 24.2.2016 |
| 22.2.2016 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | 24.2.2016 |
| 22.2.2016 | Scintimun | CIS bio international
  Boîte postale 32, F-91192 Gif-sur-Yvette, France | EU/1/09/602 | 24.2.2016 |
| 22.2.2016 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 24.2.2016 |
| 22.2.2016 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 24.2.2016 |
| 22.2.2016 | Zolendronska kislina Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/12/786 | 24.2.2016 |
| 24.2.2016 | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/538 | 26.2.2016 |
| 24.2.2016 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 26.2.2016 |
| 24.2.2016 | Firdapse | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 26.2.2016 |
| 24.2.2016 | Odomzo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1030 | 26.2.2016 |
| 24.2.2016 | Peyona | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/09/528 | 26.2.2016 |
| 24.2.2016 | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 3.3.2016 |
| 24.2.2016 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 26.2.2016 |
| 24.2.2016 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | 26.2.2016 |
| 24.2.2016 | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 26.2.2016 |
| 24.2.2016 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 26.2.2016 |
| 25.2.2016 | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/14/974 | 1.3.2016 |
| 26.2.2016 | Bridion | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/466 | 1.3.2016 |
| 26.2.2016 | Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover) | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 1.3.2016 |
| 26.2.2016 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 1.3.2016 |
| 26.2.2016 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/06/380 | 1.3.2016 |
| 26.2.2016 | Urorec | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/608 | 1.3.2016 |
| 26.2.2016 | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 2.3.2016 |
| 26.2.2016 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/01/200 | 1.3.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

8.2.2016

Hepsera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/251

10.2.2016

8.2.2016

Irbesartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

10.2.2016

8.2.2016

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

10.2.2016

8.2.2016

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

10.2.2016

8.2.2016

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

10.2.2016

8.2.2016

Zoledronic acid Accord

Accord Healthcare Limited

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

EU/1/13/834

10.2.2016

11.2.2016

Sevelamer carbonate Zentiva

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/952

15.2.2016

11.2.2016

Simbrinza

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/14/933

15.2.2016

11.2.2016

Sutent

Pfizer Limited

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

EU/1/06/347

15.2.2016

11.2.2016

Truvada

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/04/305

15.2.2016

11.2.2016

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/883

15.2.2016

11.2.2016

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

15.2.2016

11.2.2016

Zoledronska kislina Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

15.2.2016

11.2.2016

Zostavax

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/341

15.2.2016

11.2.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

15.2.2016

15.2.2016

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom

EU/1/14/913

17.2.2016

15.2.2016

Rivastigmine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/693

17.2.2016

18.2.2016

Aldara

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/98/080

22.2.2016

18.2.2016

Benlysta

Glaxo Group Ltd

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

EU/1/11/700

22.2.2016

18.2.2016

Biopoin

Teva GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/565

22.2.2016

18.2.2016

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

22.2.2016

18.2.2016

BYDUREON

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/696

22.2.2016

18.2.2016

Hizentra

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/11/687

22.2.2016

18.2.2016

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

22.2.2016

18.2.2016

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

22.2.2016

18.2.2016

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

22.2.2016

18.2.2016

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

22.2.2016

18.2.2016

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

22.2.2016

18.2.2016

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

22.2.2016

18.2.2016

TOBI Podhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/652

22.2.2016

18.2.2016

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

22.2.2016

18.2.2016

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

22.2.2016

22.2.2016

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

24.2.2016

22.2.2016

Constella

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland

EU/1/12/801

24.2.2016

22.2.2016

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/573

24.2.2016

22.2.2016

Fasturtec

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/00/170

24.2.2016

22.2.2016

Herceptin

Roche Registration Limited

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

EU/1/00/145

24.2.2016

22.2.2016

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

24.2.2016

22.2.2016

Scintimun

CIS bio international

Boîte postale 32, F-91192 Gif-sur-Yvette, France

EU/1/09/602

24.2.2016

22.2.2016

Tygacil

Pfizer Limited

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

EU/1/06/336

24.2.2016

22.2.2016

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

24.2.2016

22.2.2016

Zolendronska kislina Mylan

Mylan S.A.S

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

EU/1/12/786

24.2.2016

24.2.2016

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/538

26.2.2016

24.2.2016

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

26.2.2016

24.2.2016

Firdapse

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

26.2.2016

24.2.2016

Odomzo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1030

26.2.2016

24.2.2016

Peyona

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

26.2.2016

24.2.2016

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

3.3.2016

24.2.2016

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

26.2.2016

24.2.2016

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

26.2.2016

24.2.2016

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

26.2.2016

24.2.2016

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

26.2.2016

25.2.2016

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/14/974

1.3.2016

26.2.2016

Bridion

Merck Sharp & Dohme Limited

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

EU/1/08/466

1.3.2016

26.2.2016

Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover)

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

1.3.2016

26.2.2016

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

1.3.2016

26.2.2016

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/06/380

1.3.2016

26.2.2016

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608

1.3.2016

26.2.2016

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

2.3.2016

26.2.2016

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/01/200

1.3.2016

—   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 |
| --- | --- | --- | --- | --- |
| 24.2.2016 | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314 | 29.2.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

24.2.2016

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314

29.2.2016

—   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 |
| --- | --- | --- | --- | --- |
| 10.2.2016 | Zactran | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/08/082 | 12.2.2016 |
| 25.2.2016 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/137 | 29.2.2016 |
| 25.2.2016 | Vectra 3D | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/13/156 | 29.2.2016 |
| 25.2.2016 | Vectra Felis | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/14/165 | 29.2.2016 |
| 26.2.2016 | Econor | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/010 | 1.3.2016 |
| 26.2.2016 | Trifexis | Eli Lilly and Company Ltd, Elanco Animal Health
  Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/13/155 | 1.3.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

10.2.2016

Zactran

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/082

12.2.2016

25.2.2016

Activyl Tick Plus

Intervet International B.V.

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

EU/2/11/137

29.2.2016

25.2.2016

Vectra 3D

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/13/156

29.2.2016

25.2.2016

Vectra Felis

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/14/165

29.2.2016

26.2.2016

Econor

Elanco Europe Ltd.

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

EU/2/98/010

1.3.2016

26.2.2016

Trifexis

Eli Lilly and Company Ltd, Elanco Animal Health

Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/13/155

1.3.2016

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.

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