# Službeni list C 211/26.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 211 |
| | |
| Hrvatsko izdanje | Informacije i objave | Svezak 58.26. lipnja 2015. |

ISSN 1977-1088

Službeni list

Europske unije

C 211

Hrvatsko izdanje

Informacije i objave

Svezak 58.26. lipnja 2015.

---

| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2015/C 211/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2015. do 31. svibnja 2015.(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

2015/C 211/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2015. do 31. svibnja 2015.(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

---

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

HR

---

IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 26.6.2015 | HR | Službeni list Europske unije | C 211/1 |
| --- | --- | --- | --- |

26.6.2015

HR

Službeni list Europske unije

C 211/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2015. do 31. svibnja 2015.

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

(2015/C 211/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.5.2015. | Zykadia | ceritinib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | Kapsula, tvrda | L01XE | 8.5.2015. |
| 27.5.2015. | Akynzeo | netupitant/palonozetron | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/15/1001 | Kapsula, tvrda | A04AA55 | 29.5.2015. |
| 27.5.2015. | Jinarc | tolvaptan | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | Tableta | Pending | 29.5.2015. |
| 27.5.2015. | Synjardy | empagliflozin/metformin | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | Filmom obložena tableta | A10BD20 | 29.5.2015. |
| 27.5.2015. | Vorikonazol Hospira | vorikonazol | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1004 | Prašak za otopinu za infuziju | J02AC03 | 29.5.2015. |
| 28.5.2015. | Lenvima | lenvatinib | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/15/1002 | Kapsula, tvrda | L01XE29 | 1.6.2015. |

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

6.5.2015.

Zykadia

ceritinib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

Kapsula, tvrda

L01XE

8.5.2015.

27.5.2015.

Akynzeo

netupitant/palonozetron

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/15/1001

Kapsula, tvrda

A04AA55

29.5.2015.

27.5.2015.

Jinarc

tolvaptan

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

Tableta

Pending

29.5.2015.

27.5.2015.

Synjardy

empagliflozin/metformin

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

Filmom obložena tableta

A10BD20

29.5.2015.

27.5.2015.

Vorikonazol Hospira

vorikonazol

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/15/1004

Prašak za otopinu za infuziju

J02AC03

29.5.2015.

28.5.2015.

Lenvima

lenvatinib

Eisai Europe Limited

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

EU/1/15/1002

Kapsula, tvrda

L01XE29

1.6.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 5.5.2015. | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 7.5.2015. |
| 5.5.2015. | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 7.5.2015. |
| 5.5.2015. | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 7.5.2015. |
| 5.5.2015. | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 7.5.2015. |
| 5.5.2015. | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 8.5.2015. |
| 5.5.2015. | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 7.5.2015. |
| 5.5.2015. | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 7.5.2015. |
| 5.5.2015. | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 7.5.2015. |
| 5.5.2015. | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 7.5.2015. |
| 5.5.2015. | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 8.5.2015. |
| 5.5.2015. | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 8.5.2015. |
| 5.5.2015. | Sycrest | Organon N.V.
  Kloosterstraat 6, NL-5349 AB Oss, Nederland | EU/1/10/640 | 7.5.2015. |
| 5.5.2015. | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 8.5.2015. |
| 5.5.2015. | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 7.5.2015. |
| 5.5.2015. | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 7.5.2015. |
| 5.5.2015. | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 7.5.2015. |
| 5.5.2015. | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 7.5.2015. |
| 5.5.2015. | Zoledronic acid Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/772 | 7.5.2015. |
| 5.5.2015. | Zypadhera | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/479 | 7.5.2015. |
| 6.5.2015. | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 8.5.2015. |
| 6.5.2015. | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 8.5.2015. |
| 6.5.2015. | Celvapan | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/08/506 | 8.5.2015. |
| 6.5.2015. | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 8.5.2015. |
| 6.5.2015. | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 8.5.2015. |
| 6.5.2015. | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 8.5.2015. |
| 6.5.2015. | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 8.5.2015. |
| 6.5.2015. | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 8.5.2015. |
| 13.5.2015. | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 19.5.2015. |
| 13.5.2015. | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.5.2015. |
| 13.5.2015. | Granupas | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/896 | 19.5.2015. |
| 13.5.2015. | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.5.2015. |
| 13.5.2015. | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 19.5.2015. |
| 13.5.2015. | Luminity | Lantheus MI UK Limited
  Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom | EU/1/06/361 | 19.5.2015. |
| 13.5.2015. | Memantine Merz | Merz Pharmaceuticals GmbH
  Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland | EU/1/12/799 | 19.5.2015. |
| 13.5.2015. | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165 | 19.5.2015. |
| 13.5.2015. | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 19.5.2015. |
| 13.5.2015. | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.5.2015. |
| 13.5.2015. | Vyndaqel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/11/717 | 19.5.2015. |
| 27.5.2015. | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 29.5.2015. |
| 27.5.2015. | Ariclaim | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/283 | 29.5.2015. |
| 27.5.2015. | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 29.5.2015. |
| 27.5.2015. | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland | EU/1/09/555 | 29.5.2015. |
| 27.5.2015. | Cometriq | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/13/890 | 29.5.2015. |
| 27.5.2015. | Cymbalta | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/296 | 29.5.2015. |
| 27.5.2015. | Erivedge | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | 29.5.2015. |
| 27.5.2015. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/12/750 | 29.5.2015. |
| 27.5.2015. | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 29.5.2015. |
| 27.5.2015. | Gardasil | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 29.5.2015. |
| 27.5.2015. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 29.5.2015. |
| 27.5.2015. | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 29.5.2015. |
| 27.5.2015. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.5.2015. |
| 27.5.2015. | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 29.5.2015. |
| 27.5.2015. | Levetiracetam Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/712 | 29.5.2015. |
| 27.5.2015. | Myclausen | Herbert J. Passauer GmbH & Co. KG
  Stubenrauchstrasse 33, D-14167 Berlin, Deutschland | EU/1/10/647 | 29.5.2015. |
| 27.5.2015. | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 29.5.2015. |
| 27.5.2015. | Nivestim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631 | 29.5.2015. |
| 27.5.2015. | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 29.5.2015. |
| 27.5.2015. | Raloxifene Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/627 | 29.6.2015. |
| 27.5.2015. | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 29.5.2015. |
| 27.5.2015. | Resolor | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/09/581 | 29.5.2015. |
| 27.5.2015. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | 29.5.2015. |
| 27.5.2015. | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 29.5.2015. |
| 27.5.2015. | Sonata | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/99/102 | 29.5.2015. |
| 27.5.2015. | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 29.5.2015. |
| 27.5.2015. | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 29.5.2015. |
| 27.5.2015. | Temodal | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/98/096 | 29.5.2015. |
| 27.5.2015. | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 29.5.2015. |
| 27.5.2015. | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 29.5.2015. |
| 27.5.2015. | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 29.5.2015. |
| 27.5.2015. | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 29.5.2015. |
| 27.5.2015. | Xeristar | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/297 | 29.5.2015. |
| 27.5.2015. | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 29.5.2015. |
| 27.5.2015. | Yentreve | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/04/280 | 29.5.2015. |
| 27.5.2015. | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 29.5.2015. |
| 28.5.2015. | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 1.6.2015. |
| 28.5.2015. | alli | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/401 | 1.6.2015. |
| 28.5.2015. | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/11/733 | 1.6.2015. |
| 28.5.2015. | Invega | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/07/395 | 1.6.2015. |
| 28.5.2015. | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 1.6.2015. |
| 28.5.2015. | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 1.6.2015. |
| 28.5.2015. | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 1.6.2015. |
| 28.5.2015. | Topotecan Hospira | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/633 | 1.6.2015. |
| 28.5.2015. | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 1.6.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

5.5.2015.

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

7.5.2015.

5.5.2015.

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

7.5.2015.

5.5.2015.

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

7.5.2015.

5.5.2015.

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

7.5.2015.

5.5.2015.

Erivedge

Roche Registration Limited

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

EU/1/13/848

8.5.2015.

5.5.2015.

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

7.5.2015.

5.5.2015.

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

7.5.2015.

5.5.2015.

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

7.5.2015.

5.5.2015.

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

7.5.2015.

5.5.2015.

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

8.5.2015.

5.5.2015.

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

8.5.2015.

5.5.2015.

Sycrest

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/10/640

7.5.2015.

5.5.2015.

Tamiflu

Roche Registration Limited

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

EU/1/02/222

8.5.2015.

5.5.2015.

Telzir

ViiV Healthcare UK Limited

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

EU/1/04/282

7.5.2015.

5.5.2015.

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

7.5.2015.

5.5.2015.

Voncento

CSL Behring GmbH

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

EU/1/13/857

7.5.2015.

5.5.2015.

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

7.5.2015.

5.5.2015.

Zoledronic acid Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/772

7.5.2015.

5.5.2015.

Zypadhera

Eli Lilly Nederland B.V.

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

EU/1/08/479

7.5.2015.

6.5.2015.

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

8.5.2015.

6.5.2015.

Celsentri

ViiV Healthcare UK Limited

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

EU/1/07/418

8.5.2015.

6.5.2015.

Celvapan

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506

8.5.2015.

6.5.2015.

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

8.5.2015.

6.5.2015.

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

8.5.2015.

6.5.2015.

Optaflu

Novartis Influenza Vaccines Marburg GmbH

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

EU/1/07/394

8.5.2015.

6.5.2015.

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

8.5.2015.

6.5.2015.

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

8.5.2015.

13.5.2015.

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

19.5.2015.

13.5.2015.

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

19.5.2015.

13.5.2015.

Granupas

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/896

19.5.2015.

13.5.2015.

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

19.5.2015.

13.5.2015.

Leflunomide ratiopharm

ratiopharm GmbH

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

EU/1/10/654

19.5.2015.

13.5.2015.

Luminity

Lantheus MI UK Limited

Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom

EU/1/06/361

19.5.2015.

13.5.2015.

Memantine Merz

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland

EU/1/12/799

19.5.2015.

13.5.2015.

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165

19.5.2015.

13.5.2015.

Trizivir

ViiV Healthcare UK Limited

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

EU/1/00/156

19.5.2015.

13.5.2015.

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

19.5.2015.

13.5.2015.

Vyndaqel

Pfizer Limited

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

EU/1/11/717

19.5.2015.

27.5.2015.

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/658

29.5.2015.

27.5.2015.

Ariclaim

Eli Lilly Nederland B.V.

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

EU/1/04/283

29.5.2015.

27.5.2015.

Brinavess

Cardiome UK Limited

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

EU/1/10/645

29.5.2015.

27.5.2015.

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland

EU/1/09/555

29.5.2015.

27.5.2015.

Cometriq

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/13/890

29.5.2015.

27.5.2015.

Cymbalta

Eli Lilly Nederland B.V.

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

EU/1/04/296

29.5.2015.

27.5.2015.

Erivedge

Roche Registration Limited

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

EU/1/13/848

29.5.2015.

27.5.2015.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/12/750

29.5.2015.

27.5.2015.

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

29.5.2015.

27.5.2015.

Gardasil

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

29.5.2015.

27.5.2015.

Imnovid

Celgene Europe Limited

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

EU/1/13/850

29.5.2015.

27.5.2015.

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

29.5.2015.

27.5.2015.

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

29.5.2015.

27.5.2015.

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

29.5.2015.

27.5.2015.

Levetiracetam Accord

Accord Healthcare Limited

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

EU/1/11/712

29.5.2015.

27.5.2015.

Myclausen

Herbert J. Passauer GmbH & Co. KG

Stubenrauchstrasse 33, D-14167 Berlin, Deutschland

EU/1/10/647

29.5.2015.

27.5.2015.

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

29.5.2015.

27.5.2015.

Nivestim

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631

29.5.2015.

27.5.2015.

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

29.5.2015.

27.5.2015.

Raloxifene Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/627

29.6.2015.

27.5.2015.

Relistor

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/08/463

29.5.2015.

27.5.2015.

Resolor

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/09/581

29.5.2015.

27.5.2015.

Selincro

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/12/815

29.5.2015.

27.5.2015.

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

29.5.2015.

27.5.2015.

Sonata

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/99/102

29.5.2015.

27.5.2015.

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

29.5.2015.

27.5.2015.

Targretin

Eisai Limited

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

EU/1/01/178

29.5.2015.

27.5.2015.

Temodal

Merck Sharp & Dohme Limited

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

EU/1/98/096

29.5.2015.

27.5.2015.

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

29.5.2015.

27.5.2015.

Thalidomide Celgene

Celgene Europe Limited

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

EU/1/08/443

29.5.2015.

27.5.2015.

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

29.5.2015.

27.5.2015.

Volibris

Glaxo Group Ltd

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

EU/1/08/451

29.5.2015.

27.5.2015.

Xeristar

Eli Lilly Nederland B.V.

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

EU/1/04/297

29.5.2015.

27.5.2015.

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

29.5.2015.

27.5.2015.

Yentreve

Eli Lilly Nederland B.V.

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

EU/1/04/280

29.5.2015.

27.5.2015.

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

29.5.2015.

28.5.2015.

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

1.6.2015.

28.5.2015.

alli

Glaxo Group Ltd

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

EU/1/07/401

1.6.2015.

28.5.2015.

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/11/733

1.6.2015.

28.5.2015.

Invega

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

1.6.2015.

28.5.2015.

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

1.6.2015.

28.5.2015.

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

1.6.2015.

28.5.2015.

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

1.6.2015.

28.5.2015.

Topotecan Hospira

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633

1.6.2015.

28.5.2015.

Tygacil

Pfizer Limited

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

EU/1/06/336

1.6.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 5.5.2015. | Clopidogrel DURA | Mylan dura GmbH
  Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560 | 7.5.2015. |
| 6.5.2015. | Provenge | Dendreon UK Limited
  41 Chalton Street, London NW1 1JD, United Kingdom | EU/1/13/867 | 8.5.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

5.5.2015.

Clopidogrel DURA

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560

7.5.2015.

6.5.2015.

Provenge

Dendreon UK Limited

41 Chalton Street, London NW1 1JD, United Kingdom

EU/1/13/867

8.5.2015.

—   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 |
| --- | --- | --- | --- | --- |
| 5.5.2015. | MS-H vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 7.5.2015. |
| 5.5.2015. | Purevax RCP | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/052 | 7.5.2015. |
| 13.5.2015. | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 19.5.2015. |
| 13.5.2015. | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 19.5.2015. |
| 27.5.2015. | Meloxivet | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/07/077 | 29.5.2015. |
| 27.5.2015. | Purevax FeLV | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/00/019 | 29.5.2015. |
| 27.5.2015. | Purevax RCPCh | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/050 | 29.5.2015. |
| 27.5.2015. | Suprelorin | VIRBAC S.A.
  1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France | EU/2/07/072 | 29.5.2015. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

5.5.2015.

MS-H vaccine

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

7.5.2015.

5.5.2015.

Purevax RCP

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/052

7.5.2015.

13.5.2015.

Nobilis IB 4-91

Intervet International B.V.

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

EU/2/98/006

19.5.2015.

13.5.2015.

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

19.5.2015.

27.5.2015.

Meloxivet

Eli Lilly and Company Limited

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

EU/2/07/077

29.5.2015.

27.5.2015.

Purevax FeLV

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/00/019

29.5.2015.

27.5.2015.

Purevax RCPCh

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/050

29.5.2015.

27.5.2015.

Suprelorin

VIRBAC S.A.

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

EU/2/07/072

29.5.2015.

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

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK – LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK – LONDON E14 5EU

---

(1)  SL L 136, 30.4.04, str. 1.

---