# Službeni list C 465/27.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 465 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 61.27. prosinca 2018. |

ISSN 1977-1088

Službeni list

Europske unije

C 465

Hrvatsko izdanje

Informacije i objave

Godište 61.27. prosinca 2018.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2018/C 465/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. studenoga 2018. do 30. studenoga 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 465/01

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

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 27.12.2018 | HR | Službeni list Europske unije | C 465/1 |
| --- | --- | --- | --- |

27.12.2018

HR

Službeni list Europske unije

C 465/1

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

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

(2018/C 465/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.11.2018. | Emgality | galkanezumab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/18/1330 | Otopina za injekciju | N02CX08 | 16.11.2018. |
| 20.11.2018. | Apealea | paklitaksel | Oasmia Pharmaceutical AB
  Vallongatan 1, 75228 Uppsala, Sverige | EU/1/18/1292 | Prašak za otopinu za infuziju | L01CD01 | 22.11.2018. |
| 20.11.2018. | Buvidal | buprenorfin | Camurus AB
  Ideon Science Park, 223 70 Lund, Sverige | EU/1/18/1336 | Otopina za injekciju s produljenim oslobađanjem | N07BC01 | 22.11.2018. |
| 20.11.2018. | Fulphila | pegfilgrastim | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1329 | Otopina za injekciju | L03AA13 | 22.11.2018. |
| 20.11.2018. | Pelmeg | pegfilgrastim | Cinfa Biotech S.L.
  Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España | EU/1/18/1328 | Otopina za injekciju | L03AA13 | 22.11.2018. |
| 20.11.2018. | Vabomere | meropenem/vaborbaktam | Rempex London Limited
  115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom | EU/1/18/1334 | Prašak za koncentrat za otopinu za infuziju | J01DH52 | 22.11.2018. |
| 20.11.2018. | Venclyxto | venetoklaks | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | Filmom obložena tableta | L01XX52 | 22.11.2018. |
| 22.11.2018. | Alunbrig | brigatinib | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/18/1264 | Filmom obložena tableta | L01XE43 | 26.11.2018. |
| 22.11.2018. | Delstrigo | doravirin/lamivudin/tenofovirdizoproksil | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1333 | Filmom obložena tableta | J05AG24 | 26.11.2018. |
| 22.11.2018. | Jivi | damoktokog alfa pegol | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/18/1324 | Prašak i otapalo za otopinu za injekciju | B02BD02 | 26.11.2018. |
| 22.11.2018. | Luxturna | voretigen neparvovek | Spark Therapeutics Ireland Ltd
  Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland | EU/1/18/1331 | Koncentrat i otapalo za otopinu za injekciju | Pending | 5.12.2018. |
| 22.11.2018. | Pifeltro | doravirin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1332 | Filmom obložena tableta | J05AG06 | 27.11.2018. |
| 22.11.2018. | Poteligeo | Mogamulizumab | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/18/1335 | Koncentrat za otopinu za infuziju | L01XC25 | 26.11.2018. |
| 22.11.2018. | TAKHZYRO | lanadelumab | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, IRELAND | EU/1/18/1340 | Otopina za injekciju | B06AC05 | 26.11.2018. |
| 22.11.2018. | Ziextenzo | pegfilgrastim | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1327 | Otopina za injekciju | L03AA13 | 26.11.2018. |

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

14.11.2018.

Emgality

galkanezumab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

Otopina za injekciju

N02CX08

16.11.2018.

20.11.2018.

Apealea

paklitaksel

Oasmia Pharmaceutical AB

Vallongatan 1, 75228 Uppsala, Sverige

EU/1/18/1292

Prašak za otopinu za infuziju

L01CD01

22.11.2018.

20.11.2018.

Buvidal

buprenorfin

Camurus AB

Ideon Science Park, 223 70 Lund, Sverige

EU/1/18/1336

Otopina za injekciju s produljenim oslobađanjem

N07BC01

22.11.2018.

20.11.2018.

Fulphila

pegfilgrastim

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1329

Otopina za injekciju

L03AA13

22.11.2018.

20.11.2018.

Pelmeg

pegfilgrastim

Cinfa Biotech S.L.

Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España

EU/1/18/1328

Otopina za injekciju

L03AA13

22.11.2018.

20.11.2018.

Vabomere

meropenem/vaborbaktam

Rempex London Limited

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

EU/1/18/1334

Prašak za koncentrat za otopinu za infuziju

J01DH52

22.11.2018.

20.11.2018.

Venclyxto

venetoklaks

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

Filmom obložena tableta

L01XX52

22.11.2018.

22.11.2018.

Alunbrig

brigatinib

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

Filmom obložena tableta

L01XE43

26.11.2018.

22.11.2018.

Delstrigo

doravirin/lamivudin/tenofovirdizoproksil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1333

Filmom obložena tableta

J05AG24

26.11.2018.

22.11.2018.

Jivi

damoktokog alfa pegol

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

Prašak i otapalo za otopinu za injekciju

B02BD02

26.11.2018.

22.11.2018.

Luxturna

voretigen neparvovek

Spark Therapeutics Ireland Ltd

Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland

EU/1/18/1331

Koncentrat i otapalo za otopinu za injekciju

Pending

5.12.2018.

22.11.2018.

Pifeltro

doravirin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

Filmom obložena tableta

J05AG06

27.11.2018.

22.11.2018.

Poteligeo

Mogamulizumab

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/18/1335

Koncentrat za otopinu za infuziju

L01XC25

26.11.2018.

22.11.2018.

TAKHZYRO

lanadelumab

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, IRELAND

EU/1/18/1340

Otopina za injekciju

B06AC05

26.11.2018.

22.11.2018.

Ziextenzo

pegfilgrastim

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

Otopina za injekciju

L03AA13

26.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 8.11.2018. | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/15/1074 | 13.11.2018. |
| 8.11.2018. | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/15/1074 | 15.11.2018. |
| 8.11.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | 12.11.2018. |
| 8.11.2018. | Flixabi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/16/1106 | 15.11.2018. |
| 8.11.2018. | Irbesartan HCT Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/06/377 | 12.11.2018. |
| 8.11.2018. | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 12.11.2018. |
| 8.11.2018. | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1241 | 16.11.2018. |
| 8.11.2018. | Ruconest | Pharming Group N.V.
  Darwinweg 24, 2333 CR Leiden, Nederland | EU/1/10/641 | 12.11.2018. |
| 8.11.2018. | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 12.11.2018. |
| 8.11.2018. | Tracleer | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/02/220 | 12.11.2018. |
| 8.11.2018. | Xeljanz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1178 | 12.11.2018. |
| 12.11.2018. | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/13/909 | 14.11.2018. |
| 12.11.2018. | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 14.11.2018. |
| 12.11.2018. | Clopidogrel ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/975 | 14.11.2018. |
| 12.11.2018. | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/11/746 | 14.11.2018. |
| 12.11.2018. | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 14.11.2018. |
| 12.11.2018. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 14.11.2018. |
| 12.11.2018. | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 14.11.2018. |
| 12.11.2018. | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 14.11.2018. |
| 12.11.2018. | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/15/1000 | 14.11.2018. |
| 12.11.2018. | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 14.11.2018. |
| 12.11.2018. | Olanzapine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/08/475 | 7.12.2018. |
| 12.11.2018. | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 14.11.2018. |
| 14.11.2018. | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 16.11.2018. |
| 14.11.2018. | Daptomycin Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/17/1175 | 16.11.2018. |
| 14.11.2018. | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 16.11.2018. |
| 14.11.2018. | Izba | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/905 | 16.11.2018. |
| 14.11.2018. | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | EU/1/14/913 | 16.11.2018. |
| 14.11.2018. | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 16.11.2018. |
| 14.11.2018. | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 16.11.2018. |
| 20.11.2018. | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/17/1192 | 22.11.2018. |
| 20.11.2018. | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/13/891 | 22.11.2018. |
| 20.11.2018. | Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 22.11.2018. |
| 20.11.2018. | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 22.11.2018. |
| 20.11.2018. | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 22.11.2018. |
| 20.11.2018. | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/889 | 22.11.2018. |
| 20.11.2018. | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | EU/1/13/906 | 22.11.2018. |
| 20.11.2018. | NovoSeven | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/96/006 | 22.11.2018. |
| 20.11.2018. | Orfadin | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/04/303 | 23.11.2018. |
| 20.11.2018. | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 22.11.2018. |
| 20.11.2018. | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 22.11.2018. |
| 20.11.2018. | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 22.11.2018. |
| 20.11.2018. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 22.11.2018. |
| 20.11.2018. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 22.11.2018. |
| 20.11.2018. | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 22.11.2018. |
| 20.11.2018. | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 22.11.2018. |
| 22.11.2018. | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 26.11.2018. |
| 22.11.2018. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 26.11.2018. |
| 22.11.2018. | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/07/384 | 26.11.2018. |
| 22.11.2018. | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/08/503 | 26.11.2018. |
| 22.11.2018. | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/848 | 26.11.2018. |
| 22.11.2018. | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/677 | 28.11.2018. |
| 22.11.2018. | Inlyta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/777 | 26.11.2018. |
| 22.11.2018. | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 26.11.2018. |
| 22.11.2018. | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/12/782 | 26.11.2018. |
| 22.11.2018. | Kentera | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/03/270 | 26.11.2018. |
| 22.11.2018. | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 26.11.2018. |
| 22.11.2018. | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/889 | 26.11.2018. |
| 22.11.2018. | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 26.11.2018. |
| 22.11.2018. | Nyxoid | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/17/1238 | 26.11.2018. |
| 22.11.2018. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 26.11.2018. |
| 22.11.2018. | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 27.11.2018. |
| 22.11.2018. | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 26.11.2018. |
| 22.11.2018. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 26.11.2018. |
| 22.11.2018. | Wakix | Bioprojet Pharma
  9 rue Rameau, 75002 Pariz, France | EU/1/15/1068 | 26.11.2018. |
| 22.11.2018. | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 26.11.2018. |
| 26.11.2018. | alli | GlaxoSmithKline Dungarvan Limited
  Knockbrack, Dungarvan, Co. Waterford, Ireland | EU/1/07/401 | 29.11.2018. |
| 26.11.2018. | Anoro Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 28.11.2018. |
| 26.11.2018. | Darunavir Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1248 | 28.11.2018. |
| 26.11.2018. | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/07/384 | 28.11.2018. |
| 26.11.2018. | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/12/782 | 28.11.2018. |
| 26.11.2018. | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/10/654 | 28.11.2018. |
| 26.11.2018. | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/15/1059 | 28.11.2018. |
| 26.11.2018. | PHEBURANE | Eurocept International BV
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/822 | 28.11.2018. |
| 26.11.2018. | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/114 | 28.11.2018. |
| 28.11.2018. | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 30.11.2018. |
| 28.11.2018. | Pregabalin Zentiva k.s | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1166 | 30.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

8.11.2018.

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

13.11.2018.

8.11.2018.

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

15.11.2018.

8.11.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

12.11.2018.

8.11.2018.

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/16/1106

15.11.2018.

8.11.2018.

Irbesartan HCT Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

12.11.2018.

8.11.2018.

Neupro

UCB Pharma S.A.

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

EU/1/05/331

12.11.2018.

8.11.2018.

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

16.11.2018.

8.11.2018.

Ruconest

Pharming Group N.V.

Darwinweg 24, 2333 CR Leiden, Nederland

EU/1/10/641

12.11.2018.

8.11.2018.

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

12.11.2018.

8.11.2018.

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

12.11.2018.

8.11.2018.

Xeljanz

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/17/1178

12.11.2018.

12.11.2018.

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/13/909

14.11.2018.

12.11.2018.

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

14.11.2018.

12.11.2018.

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

14.11.2018.

12.11.2018.

Desloratadine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

14.11.2018.

12.11.2018.

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

14.11.2018.

12.11.2018.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

14.11.2018.

12.11.2018.

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

14.11.2018.

12.11.2018.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

14.11.2018.

12.11.2018.

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/15/1000

14.11.2018.

12.11.2018.

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

14.11.2018.

12.11.2018.

Olanzapine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/08/475

7.12.2018.

12.11.2018.

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

14.11.2018.

14.11.2018.

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

16.11.2018.

14.11.2018.

Daptomycin Hospira

Hospira UK Limited

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

EU/1/17/1175

16.11.2018.

14.11.2018.

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

16.11.2018.

14.11.2018.

Izba

Novartis Europharm Limited

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

EU/1/13/905

16.11.2018.

14.11.2018.

Latuda

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

16.11.2018.

14.11.2018.

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

16.11.2018.

14.11.2018.

Tecfidera

Biogen Idec Limited

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

EU/1/13/837

16.11.2018.

20.11.2018.

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

22.11.2018.

20.11.2018.

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

22.11.2018.

20.11.2018.

Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

22.11.2018.

20.11.2018.

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

22.11.2018.

20.11.2018.

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

22.11.2018.

20.11.2018.

Levetiracetam Hospira

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/13/889

22.11.2018.

20.11.2018.

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

22.11.2018.

20.11.2018.

NovoSeven

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/96/006

22.11.2018.

20.11.2018.

Orfadin

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/04/303

23.11.2018.

20.11.2018.

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

22.11.2018.

20.11.2018.

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

22.11.2018.

20.11.2018.

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

22.11.2018.

20.11.2018.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

22.11.2018.

20.11.2018.

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

22.11.2018.

20.11.2018.

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

22.11.2018.

20.11.2018.

Zoledronic acid Accord

Accord Healthcare Limited

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

EU/1/13/834

22.11.2018.

22.11.2018.

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

26.11.2018.

22.11.2018.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

26.11.2018.

22.11.2018.

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/07/384

26.11.2018.

22.11.2018.

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

26.11.2018.

22.11.2018.

Erivedge

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/13/848

26.11.2018.

22.11.2018.

GILENYA

Novartis Europharm Limited

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

EU/1/11/677

28.11.2018.

22.11.2018.

Inlyta

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/12/777

26.11.2018.

22.11.2018.

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

26.11.2018.

22.11.2018.

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

26.11.2018.

22.11.2018.

Kentera

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/03/270

26.11.2018.

22.11.2018.

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

26.11.2018.

22.11.2018.

Levetiracetam Hospira

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België

EU/1/13/889

26.11.2018.

22.11.2018.

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

26.11.2018.

22.11.2018.

Nyxoid

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

26.11.2018.

22.11.2018.

Ranexa

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/462

26.11.2018.

22.11.2018.

Soliris

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/07/393

27.11.2018.

22.11.2018.

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

26.11.2018.

22.11.2018.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

26.11.2018.

22.11.2018.

Wakix

Bioprojet Pharma

9 rue Rameau, 75002 Pariz, France

EU/1/15/1068

26.11.2018.

22.11.2018.

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

26.11.2018.

26.11.2018.

alli

GlaxoSmithKline Dungarvan Limited

Knockbrack, Dungarvan, Co. Waterford, Ireland

EU/1/07/401

29.11.2018.

26.11.2018.

Anoro Ellipta

Glaxo Group Ltd

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

EU/1/14/898

28.11.2018.

26.11.2018.

Darunavir Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

28.11.2018.

26.11.2018.

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/07/384

28.11.2018.

26.11.2018.

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

28.11.2018.

26.11.2018.

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/10/654

28.11.2018.

26.11.2018.

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/15/1059

28.11.2018.

26.11.2018.

PHEBURANE

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/822

28.11.2018.

26.11.2018.

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/114

28.11.2018.

28.11.2018.

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

30.11.2018.

28.11.2018.

Pregabalin Zentiva k.s

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

30.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 12.11.2018. | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 14.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

12.11.2018.

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

14.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 19.11.2018. | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/14/170 | 21.11.2018. |
| 19.11.2018. | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 21.11.2018. |
| 26.11.2018. | Econor | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/98/010 | 28.11.2018. |
| 26.11.2018. | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 29.11.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

19.11.2018.

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/14/170

21.11.2018.

19.11.2018.

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

21.11.2018.

26.11.2018.

Econor

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/98/010

28.11.2018.

26.11.2018.

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

29.11.2018.

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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