# Službeni list C 116/1. t

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 116 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 59.1. travnja 2016. |

ISSN 1977-1088

Službeni list

Europske unije

C 116

Hrvatsko izdanje

Informacije i objave

Svezak 59.1. travnja 2016.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2016/C 116/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2016. do 29. veljače 2016.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2016/C 116/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2016. do 29. veljače 2016.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

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

1

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 1.4.2016 | HR | Službeni list Europske unije | C 116/1 |
| --- | --- | --- | --- |

1.4.2016

HR

Službeni list Europske unije

C 116/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2016. do 29. veljače 2016.

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

(2016/C 116/01)

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

| Datum odluke | Naziv lijeka | INN (medunarodni nezašticeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.2.2016. | TAGRISSO | osimertinib | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1086 | Filmom obložena tableta | 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 | Prašak za koncentrat za otopinu za infuziju | 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 otopinu za infuziju | L01XC22 | 18.2.2016. |
| 15.2.2016. | Vaxelis | Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK), poliomijelitisa (inaktivirano) i hemofilusa tip b konjugirano, (adsorbirano) | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1079 | Suspenzija za injekciju | J07CA09 | 17.2.2016. |
| 18.2.2016. | Feraccru | feri-maltol | Iron Therapeutics (UK) Ltd
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | Kapsula, tvrda | B03AB10 | 22.2.2016. |
| 18.2.2016. | Iblias | oktokog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1077 | Prašak i otapalo za otopinu za injekciju | B02BD02 | 22.2.2016. |
| 18.2.2016. | Kovaltry | oktokog alfa | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/15/1076 | Prašak i otapalo za otopinu za injekciju | B02BD02 | 22.2.2016. |
| 18.2.2016. | Zurampic | lesinurad | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1080 | Filmom obložena tableta | M04AB05 | 22.2.2016. |

Datum odluke

Naziv lijeka

INN (medunarodni nezašticeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

2.2.2016.

TAGRISSO

osimertinib

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1086

Filmom obložena tableta

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

Prašak za koncentrat za otopinu za infuziju

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 otopinu za infuziju

L01XC22

18.2.2016.

15.2.2016.

Vaxelis

Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK), poliomijelitisa (inaktivirano) i hemofilusa tip b konjugirano, (adsorbirano)

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1079

Suspenzija za injekciju

J07CA09

17.2.2016.

18.2.2016.

Feraccru

feri-maltol

Iron Therapeutics (UK) Ltd

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

Kapsula, tvrda

B03AB10

22.2.2016.

18.2.2016.

Iblias

oktokog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1077

Prašak i otapalo za otopinu za injekciju

B02BD02

22.2.2016.

18.2.2016.

Kovaltry

oktokog alfa

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/15/1076

Prašak i otapalo za otopinu za injekciju

B02BD02

22.2.2016.

18.2.2016.

Zurampic

lesinurad

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1080

Filmom obložena tableta

M04AB05

22.2.2016.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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 Pariz, 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 Pariz, 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. | Zoledronic acid 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 Pariz, 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 Pariz, 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. | Zoledronic acid 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 Pariz, 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 odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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 Pariz, 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 Pariz, 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.

Zoledronic acid 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 Pariz, 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 Pariz, 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.

Zoledronic acid 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 Pariz, 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.

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

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 24.2.2016. | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314 | 29.2.2016. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

24.2.2016.

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314

29.2.2016.

—   Izmjena odobrenja za stavljanje u promet (članak 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno

| Datum odluke | Naziv lijeka | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Datum obavijesti |
| --- | --- | --- | --- | --- |
| 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 odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

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.

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

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

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

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

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