# Službeni list C 266/27.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 266 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.27. srpnja 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 266

Hrvatsko izdanje

Informacije i objave

Godište 61.27. srpnja 2018.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 266/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2018. do 30. lipnja 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2018/C 266/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2018. do 30. lipnja 2018.(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

| 27.7.2018 | HR | Službeni list Europske unije | C 266/1 |
| --- | --- | --- | --- |

27.7.2018

HR

Službeni list Europske unije

C 266/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. lipnja 2018. do 30. lipnja 2018.

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

(2018/C 266/01)

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

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.6.2018. | Blincyto | blinatumomab | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | Prašak za koncentrat za otopinu za infuziju | L01XC19 | 20.6.2018. |
| 21.6.2018. | Biktarvy | biktegravir / emtricitabin / tenofoviralafenamid | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/18/1289 | Filmom obložena tableta | J05AR20 | 25.6.2018. |
| 25.6.2018. | Dzuveo | Sufentanil | FGK Representative Service GmbH
  Heimeranstraße 35, 80339 München, Deutschland | EU/1/18/1284 | Sublingvalno | N01AH03 | 27.6.2018. |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

18.6.2018.

Blincyto

blinatumomab

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

Prašak za koncentrat za otopinu za infuziju

L01XC19

20.6.2018.

21.6.2018.

Biktarvy

biktegravir / emtricitabin / tenofoviralafenamid

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/18/1289

Filmom obložena tableta

J05AR20

25.6.2018.

25.6.2018.

Dzuveo

Sufentanil

FGK Representative Service GmbH

Heimeranstraße 35, 80339 München, Deutschland

EU/1/18/1284

Sublingvalno

N01AH03

27.6.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 4.6.2018. | Copalia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/372 | 6.6.2018. |
| 4.6.2018. | Emtriva | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/261 | 6.6.2018. |
| 4.6.2018. | Iclusig | Incyte Biosciences Distribution B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/13/839 | 6.6.2018. |
| 4.6.2018. | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 6.6.2018. |
| 4.6.2018. | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 6.6.2018. |
| 4.6.2018. | Stribild | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/830 | 6.6.2018. |
| 4.6.2018. | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 6.6.2018. |
| 4.6.2018. | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 6.6.2018. |
| 4.6.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 6.6.2018. |
| 7.6.2018. | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 11.6.2018. |
| 7.6.2018. | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 11.6.2018. |
| 7.6.2018. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 11.6.2018. |
| 7.6.2018. | Cerdelga | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/14/974 | 11.6.2018. |
| 7.6.2018. | Cimzia | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 11.6.2018. |
| 7.6.2018. | Constella | Allergan Pharmaceuticals International Limited
  Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland | EU/1/12/801 | 11.6.2018. |
| 7.6.2018. | Dafiro | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/371 | 11.6.2018. |
| 7.6.2018. | Exforge HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/569 | 11.6.2018. |
| 7.6.2018. | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 11.6.2018. |
| 7.6.2018. | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 11.6.2018. |
| 7.6.2018. | Isentress | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/436 | 11.6.2018. |
| 7.6.2018. | Pemetrexed Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1071 | 11.6.2018. |
| 7.6.2018. | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 11.6.2018. |
| 7.6.2018. | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 11.6.2018. |
| 7.6.2018. | SomaKit TOC | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/16/1141 | 11.6.2018. |
| 7.6.2018. | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 11.6.2018. |
| 7.6.2018. | Uptravi | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | 11.6.2018. |
| 7.6.2018. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 11.6.2018. |
| 7.6.2018. | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 11.6.2018. |
| 7.6.2018. | Votubia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/710 | 11.6.2018. |
| 7.6.2018. | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 11.6.2018. |
| 7.6.2018. | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 11.6.2018. |
| 7.6.2018. | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 11.6.2018. |
| 12.6.2018. | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 14.6.2018. |
| 12.6.2018. | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 14.6.2018. |
| 12.6.2018. | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 14.6.2018. |
| 12.6.2018. | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 14.6.2018. |
| 14.6.2018. | Insuman | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/97/030 | 19.6.2018. |
| 14.6.2018. | Iscover | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/98/070 | 19.6.2018. |
| 14.6.2018. | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018. |
| 15.6.2018. | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 19.6.2018. |
| 15.6.2018. | Lusduna | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1162 | 19.6.2018. |
| 15.6.2018. | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 19.6.2018. |
| 15.6.2018. | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 19.6.2018. |
| 15.6.2018. | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 19.6.2018. |
| 15.6.2018. | Zepatier | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1119 | 19.6.2018. |
| 15.6.2018. | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 19.6.2018. |
| 15.6.2018. | ZINPLAVA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/16/1156 | 19.6.2018. |
| 21.6.2018. | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/13/854 | 25.6.2018. |
| 21.6.2018. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 25.6.2018. |
| 21.6.2018. | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/10/637 | 25.6.2018. |
| 21.6.2018. | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/149 | 25.6.2018. |
| 21.6.2018. | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 25.6.2018. |
| 21.6.2018. | Rolufta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 25.6.2018. |
| 21.6.2018. | Targretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/01/178 | 25.6.2018. |
| 21.6.2018. | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 25.6.2018. |
| 21.6.2018. | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 25.6.2018. |
| 25.6.2018. | Copalia HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/575 | 27.6.2018. |
| 25.6.2018. | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 27.6.2018. |
| 25.6.2018. | Dafiro HCT | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/574 | 27.6.2018. |
| 25.6.2018. | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 27.6.2018. |
| 25.6.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 27.6.2018. |
| 25.6.2018. | Exforge | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/370 | 27.6.2018. |
| 25.6.2018. | Glivec | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/198 | 27.6.2018. |
| 25.6.2018. | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 27.6.2018. |
| 25.6.2018. | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 27.6.2018. |
| 25.6.2018. | Orbactiv | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/15/989 | 27.6.2018. |
| 25.6.2018. | PANTOLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/519 | 27.6.2018. |
| 25.6.2018. | Pantoprazol | | | 26.6.2018. |
| 25.6.2018. | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 27.6.2018. |
| 25.6.2018. | Xeljanz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | 27.6.2018. |
| 25.6.2018. | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 27.6.2018. |
| 25.6.2018. | Yondelis | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 27.6.2018. |
| 29.6.2018. | Aerius | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/160 | 3.7.2018. |
| 29.6.2018. | Azomyr | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/00/157 | 3.7.2018. |
| 29.6.2018. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 3.7.2018. |
| 29.6.2018. | Efficib | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/457 | 3.7.2018. |
| 29.6.2018. | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 3.7.2018. |
| 29.6.2018. | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 3.7.2018. |
| 29.6.2018. | Janumet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/455 | 3.7.2018. |
| 29.6.2018. | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 3.7.2018. |
| 29.6.2018. | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 3.7.2018. |
| 29.6.2018. | Orgalutran | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/130 | 3.7.2018. |
| 29.6.2018. | Revlimid | Celgene Europe B.V.
  Winthonlaan 6N, 3526 KV Utrecht, Nederland | EU/1/07/391 | 3.7.2018. |
| 29.6.2018. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 3.7.2018. |
| 29.6.2018. | Ristfor | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/10/620 | 3.7.2018. |
| 29.6.2018. | Samsca | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/09/539 | 3.7.2018. |
| 29.6.2018. | Spectrila | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/15/1072 | 3.7.2018. |
| 29.6.2018. | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 3.7.2018. |
| 29.6.2018. | Velmetia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/456 | 3.7.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.6.2018.

Copalia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/372

6.6.2018.

4.6.2018.

Emtriva

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/261

6.6.2018.

4.6.2018.

Iclusig

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/13/839

6.6.2018.

4.6.2018.

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

6.6.2018.

4.6.2018.

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

6.6.2018.

4.6.2018.

Stribild

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

6.6.2018.

4.6.2018.

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

6.6.2018.

4.6.2018.

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

6.6.2018.

4.6.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

6.6.2018.

7.6.2018.

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

11.6.2018.

7.6.2018.

BeneFIX

Pfizer Limited

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

EU/1/97/047

11.6.2018.

7.6.2018.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

11.6.2018.

7.6.2018.

Cerdelga

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/14/974

11.6.2018.

7.6.2018.

Cimzia

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

11.6.2018.

7.6.2018.

Constella

Allergan Pharmaceuticals International Limited

Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland

EU/1/12/801

11.6.2018.

7.6.2018.

Dafiro

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/371

11.6.2018.

7.6.2018.

Exforge HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/569

11.6.2018.

7.6.2018.

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

11.6.2018.

7.6.2018.

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

11.6.2018.

7.6.2018.

Isentress

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/436

11.6.2018.

7.6.2018.

Pemetrexed Accord

Accord Healthcare Limited

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

EU/1/15/1071

11.6.2018.

7.6.2018.

Pradaxa

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442

11.6.2018.

7.6.2018.

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

11.6.2018.

7.6.2018.

SomaKit TOC

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/16/1141

11.6.2018.

7.6.2018.

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

11.6.2018.

7.6.2018.

Uptravi

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/15/1083

11.6.2018.

7.6.2018.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

11.6.2018.

7.6.2018.

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

11.6.2018.

7.6.2018.

Votubia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/11/710

11.6.2018.

7.6.2018.

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

11.6.2018.

7.6.2018.

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

11.6.2018.

7.6.2018.

Zykadia

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/15/999

11.6.2018.

12.6.2018.

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

14.6.2018.

12.6.2018.

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

14.6.2018.

12.6.2018.

Incruse

Glaxo Group Ltd

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

EU/1/14/922

14.6.2018.

12.6.2018.

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

14.6.2018.

14.6.2018.

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030

19.6.2018.

14.6.2018.

Iscover

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/070

19.6.2018.

14.6.2018.

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018.

15.6.2018.

Aerinaze

Merck Sharp & Dohme Limited

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

EU/1/07/399

19.6.2018.

15.6.2018.

Lusduna

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1162

19.6.2018.

15.6.2018.

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

19.6.2018.

15.6.2018.

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

19.6.2018.

15.6.2018.

Xyrem

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/05/312

19.6.2018.

15.6.2018.

Zepatier

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

19.6.2018.

15.6.2018.

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

19.6.2018.

15.6.2018.

ZINPLAVA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1156

19.6.2018.

21.6.2018.

Inflectra

Hospira UK Limited

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

EU/1/13/854

25.6.2018.

21.6.2018.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

25.6.2018.

21.6.2018.

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/10/637

25.6.2018.

21.6.2018.

Panretin

Eisai Limited

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

EU/1/00/149

25.6.2018.

21.6.2018.

Remsima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

25.6.2018.

21.6.2018.

Rolufta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

25.6.2018.

21.6.2018.

Targretin

Eisai Limited

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

EU/1/01/178

25.6.2018.

21.6.2018.

Xeljanz

Pfizer Limited

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

EU/1/17/1178

25.6.2018.

21.6.2018.

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

25.6.2018.

25.6.2018.

Copalia HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/575

27.6.2018.

25.6.2018.

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

27.6.2018.

25.6.2018.

Dafiro HCT

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/09/574

27.6.2018.

25.6.2018.

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

27.6.2018.

25.6.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

27.6.2018.

25.6.2018.

Exforge

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/370

27.6.2018.

25.6.2018.

Glivec

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/01/198

27.6.2018.

25.6.2018.

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

27.6.2018.

25.6.2018.

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

27.6.2018.

25.6.2018.

Orbactiv

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/15/989

27.6.2018.

25.6.2018.

PANTOLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/519

27.6.2018.

25.6.2018.

Pantoprazol

26.6.2018.

25.6.2018.

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

27.6.2018.

25.6.2018.

Xeljanz

Pfizer Limited

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

EU/1/17/1178

27.6.2018.

25.6.2018.

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

27.6.2018.

25.6.2018.

Yondelis

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

EU/1/07/417

27.6.2018.

29.6.2018.

Aerius

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/160

3.7.2018.

29.6.2018.

Azomyr

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/157

3.7.2018.

29.6.2018.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

3.7.2018.

29.6.2018.

Efficib

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/457

3.7.2018.

29.6.2018.

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

3.7.2018.

29.6.2018.

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

3.7.2018.

29.6.2018.

Janumet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/455

3.7.2018.

29.6.2018.

Jinarc

Otsuka Pharmaceutical Europe Ltd

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

EU/1/15/1000

3.7.2018.

29.6.2018.

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

3.7.2018.

29.6.2018.

Orgalutran

Merck Sharp & Dohme Limited

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

EU/1/00/130

3.7.2018.

29.6.2018.

Revlimid

Celgene Europe B.V.

Winthonlaan 6N, 3526 KV Utrecht, Nederland

EU/1/07/391

3.7.2018.

29.6.2018.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

3.7.2018.

29.6.2018.

Ristfor

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/10/620

3.7.2018.

29.6.2018.

Samsca

Otsuka Pharmaceutical Europe Ltd

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

EU/1/09/539

3.7.2018.

29.6.2018.

Spectrila

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

3.7.2018.

29.6.2018.

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

3.7.2018.

29.6.2018.

Velmetia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/456

3.7.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 15.6.2018. | SOLYMBIC | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1163 | 19.6.2018. |
| 21.6.2018. | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 25.6.2018. |
| 29.6.2018. | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 3.7.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

15.6.2018.

SOLYMBIC

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1163

19.6.2018.

21.6.2018.

Angiox

The Medicines Company UK Ltd

115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom

EU/1/04/289

25.6.2018.

29.6.2018.

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

3.7.2018.

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

—

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

| Datum odluke | Naziv lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj odobrenja za stavljanje u promet | Broj upisa u registar Zajednice | Farmaceutski oblik | Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) | Datum obavijesti |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.6.2018. | Dany's BienenWohl | dihidrat oksalne kiseline | Dany Bienenwohl GmbH
  Geyerspergerstraße 27, 80689 München, Deutschland | EU/2/18/225 | Prah i otopina za disperziju za košnice | QP53AG03 | 19.6.2018. |

Datum odluke

Naziv lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Farmaceutski oblik

Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova)

Datum obavijesti

14.6.2018.

Dany's BienenWohl

dihidrat oksalne kiseline

Dany Bienenwohl GmbH

Geyerspergerstraße 27, 80689 München, Deutschland

EU/2/18/225

Prah i otopina za disperziju za košnice

QP53AG03

19.6.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 4.6.2018. | Activyl | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/10/118 | 6.6.2018. |
| 4.6.2018. | Cepedex | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/16/200 | 6.6.2018. |
| 11.6.2018. | Veraflox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/10/107 | 13.6.2018. |
| 14.6.2018. | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 19.6.2018. |
| 18.6.2018. | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/109 | 20.6.2018. |
| 27.6.2018. | BROADLINE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/157 | 29.6.2018. |
| 27.6.2018. | Evalon | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/194 | 29.6.2018. |
| 27.6.2018. | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 29.6.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.6.2018.

Activyl

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118

6.6.2018.

4.6.2018.

Cepedex

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

6.6.2018.

11.6.2018.

Veraflox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/10/107

13.6.2018.

14.6.2018.

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

19.6.2018.

18.6.2018.

Rhiniseng

Laboratorios Hipra, S.A.

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

EU/2/10/109

20.6.2018.

27.6.2018.

BROADLINE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/157

29.6.2018.

27.6.2018.

Evalon

Laboratorios Hipra, S.A.

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

EU/2/16/194

29.6.2018.

27.6.2018.

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

29.6.2018.

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

---

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

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