# Službeni list C 101/27.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 101 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 63.27. ožujka 2020. |

ISSN 1977-1088

Službeni list

Europske unije

C 101

Hrvatsko izdanje

Informacije i objave

Godište 63.27. ožujka 2020.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2020/C 101/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2020. do 29. veljače 2020.(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

2020/C 101/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2020. do 29. veljače 2020.(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

| 27.3.2020 | HR | Službeni list Europske unije | C 101/1 |
| --- | --- | --- | --- |

27.3.2020

HR

Službeni list Europske unije

C 101/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2020. do 29. veljače 2020.

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

(2020/C 101/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.2.2020. | Amsparity | adalimumab | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/19/1415 | Otopina za injekciju | L04AB04 | 17.2.2020. |
| 13.2.2020. | Azacitidine Accord | Azacitidin | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1413 | prašak za suspenziju za injekciju | L01BC07 | 17.2.2020. |
| 13.2.2020. | Beovu | brolucizumab | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/19/1417 | Otopina za injekciju | S01LA06 | 17.2.2020. |
| 13.2.2020. | Dexmedetomidine Accord | deksmedetomidin | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1418 | Koncentrat za otopinu za infuziju | N05CM18 | 17.2.2020. |
| 13.2.2020. | Recarbrio | imipenem/cilastatin/relebaktam | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/19/1420 | Prašak za otopinu za infuziju | J01DH56 | 17.2.2020. |

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

13.2.2020.

Amsparity

adalimumab

Pfizer Europe MA EEIG

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

EU/1/19/1415

Otopina za injekciju

L04AB04

17.2.2020.

13.2.2020.

Azacitidine Accord

Azacitidin

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1413

prašak za suspenziju za injekciju

L01BC07

17.2.2020.

13.2.2020.

Beovu

brolucizumab

Novartis Europharm Limited

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

EU/1/19/1417

Otopina za injekciju

S01LA06

17.2.2020.

13.2.2020.

Dexmedetomidine Accord

deksmedetomidin

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/19/1418

Koncentrat za otopinu za infuziju

N05CM18

17.2.2020.

13.2.2020.

Recarbrio

imipenem/cilastatin/relebaktam

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1420

Prašak za otopinu za infuziju

J01DH56

17.2.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 4.2.2020. | Ceprotin | Takeda Manufacturing Austria AG
  Industriestraße 67, 1221 Wien, Österreich | EU/1/01/190 | 6.2.2020. |
| 4.2.2020. | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/515 | 6.2.2020. |
| 4.2.2020. | ellaOne | Laboratoire HRA Pharma
  200 avenue de Pariz, 92320 Chatillon, France | EU/1/09/522 | 6.2.2020. |
| 4.2.2020. | Ivabradin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/17/1190 | 6.2.2020. |
| 4.2.2020. | Lacosamide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1230 | 6.2.2020. |
| 4.2.2020. | LIFMIOR | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1165 | 6.2.2020. |
| 4.2.2020. | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 6.2.2020. |
| 4.2.2020. | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/517 | 6.2.2020. |
| 4.2.2020. | Suboxone | Indivior Europe Limited
  27 Windsor Place, Dublin 2, Ireland | EU/1/06/359 | 6.2.2020. |
| 4.2.2020. | Ucedane | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/17/1202 | 6.2.2020. |
| 4.2.2020. | Ziagen | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/99/112 | 6.2.2020. |
| 4.2.2020. | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | EU/1/11/690 | 6.2.2020. |
| 6.2.2020. | Aranesp | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185 | 10.2.2020. |
| 6.2.2020. | Bronchitol | Pharmaxis Europe Limited
  108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland | EU/1/12/760 | 10.2.2020. |
| 6.2.2020. | Fasenra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | 10.2.2020. |
| 6.2.2020. | Granpidam | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/16/1137 | 10.2.2020. |
| 6.2.2020. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 10.2.2020. |
| 6.2.2020. | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | EU/1/13/906 | 10.2.2020. |
| 6.2.2020. | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/516 | 10.2.2020. |
| 6.2.2020. | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 10.2.2020. |
| 10.2.2020. | Inhixa | Techdow Pharma Netherlands B.V.
  Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland | EU/1/16/1132 | 12.2.2020. |
| 11.2.2020. | Alimta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/290 | 13.2.2020. |
| 11.2.2020. | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 13.2.2020. |
| 11.2.2020. | Entecavir Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1211 | 13.2.2020. |
| 11.2.2020. | OCALIVA | Intercept Pharma International Limited
  Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland | EU/1/16/1139 | 13.2.2020. |
| 11.2.2020. | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/15/1059 | 13.2.2020. |
| 11.2.2020. | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/16/1115 | 13.2.2020. |
| 11.2.2020. | Rebetol | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/107 | 13.2.2020. |
| 11.2.2020. | Symkevi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/18/1306 | 13.2.2020. |
| 11.2.2020. | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/114 | 13.2.2020. |
| 11.2.2020. | Zevalin | Ceft Biopharma s.r.o
  Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika | EU/1/03/264 | 13.2.2020. |
| 12.2.2020. | Zoledronic acid Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/800 | 14.2.2020. |
| 13.2.2020. | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | 17.2.2020. |
| 13.2.2020. | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/818 | 17.2.2020. |
| 13.2.2020. | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/17/1192 | 17.2.2020. |
| 13.2.2020. | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/11/733 | 17.2.2020. |
| 13.2.2020. | Duloxetine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1010 | 17.2.2020. |
| 13.2.2020. | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/02/219 | 17.2.2020. |
| 13.2.2020. | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1147 | 17.2.2020. |
| 13.2.2020. | Mvasi | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | 17.2.2020. |
| 13.2.2020. | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 17.2.2020. |
| 13.2.2020. | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/06/363 | 17.2.2020. |
| 13.2.2020. | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 17.2.2020. |
| 13.2.2020. | Ventavis | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/255 | 17.2.2020. |
| 17.2.2020. | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 19.2.2020. |
| 17.2.2020. | Atripla | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/07/430 | 19.2.2020. |
| 17.2.2020. | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | EU/1/11/691 | 19.2.2020. |
| 17.2.2020. | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/050 | 19.2.2020. |
| 17.2.2020. | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Pariz, France | EU/1/16/1157 | 19.2.2020. |
| 17.2.2020. | Tacforius | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | 2.3.2020. |
| 17.2.2020. | Vyndaqel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/11/717 | 19.2.2020. |
| 18.2.2020. | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 20.2.2020. |
| 21.2.2020. | Cholib | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | EU/1/13/866 | 25.2.2020. |
| 21.2.2020. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 25.2.2020. |
| 21.2.2020. | Docetaxel Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/769 | 25.2.2020. |
| 21.2.2020. | Eptifibatid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/15/1065 | 25.2.2020. |
| 21.2.2020. | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 25.2.2020. |
| 21.2.2020. | Imfinzi | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1322 | 18.2.2020. |
| 21.2.2020. | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/04/279 | 25.2.2020. |
| 21.2.2020. | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051 | 25.2.2020. |
| 21.2.2020. | Resolor | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland | EU/1/09/581 | 25.2.2020. |
| 21.2.2020. | Trelegy Ellipta | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | EU/1/17/1236 | 25.2.2020. |
| 21.2.2020. | Voriconazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/13/835 | 25.2.2020. |
| 21.2.2020. | Zalasta | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415 | 25.2.2020. |
| 21.2.2020. | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 25.2.2020. |
| 21.2.2020. | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/99/125 | 25.2.2020. |
| 24.2.2020. | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/12/770 | 26.2.2020. |
| 24.2.2020. | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 26.2.2020. |
| 24.2.2020. | Slenyto | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Pariz, France | EU/1/18/1318 | 26.2.2020. |
| 25.2.2020. | Aripiprazole Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1005 | 27.2.2020. |
| 28.2.2020. | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/07/387 | 3.3.2020. |
| 28.2.2020. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 3.3.2020. |
| 28.2.2020. | Cuprymina | A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
  Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia | EU/1/12/784 | 3.3.2020. |
| 28.2.2020. | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland | EU/1/15/1008 | 3.3.2020. |
| 28.2.2020. | Januvia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/383 | 3.3.2020. |
| 28.2.2020. | Ledaga | Helsinn Birex Pharmaceuticals Ltd.
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/16/1171 | 3.3.2020. |
| 28.2.2020. | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/09/523 | 3.3.2020. |
| 28.2.2020. | Pegfilgrastim Mundipharma | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/19/1409 | 3.3.2020. |
| 28.2.2020. | Pemetrexed Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/15/1071 | 3.3.2020. |
| 28.2.2020. | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 3.3.2020. |
| 28.2.2020. | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 3.3.2020. |
| 28.2.2020. | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/13/857 | 3.3.2020. |
| 28.2.2020. | Xerava | Tetraphase Pharmaceuticals Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | EU/1/18/1312 | 3.3.2020. |
| 28.2.2020. | Xeristar | Esteve Pharmaceuticals S.A.
  Passeig de la Zona Franca, 109, 08038 Barcelona, España | EU/1/04/297 | 3.3.2020. |
| 28.2.2020. | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 3.3.2020. |
| 28.2.2020. | Zoledronic acid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/834 | 3.3.2020. |
| 28.2.2020. | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/938 | 3.3.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.2.2020.

Ceprotin

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

EU/1/01/190

6.2.2020.

4.2.2020.

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

6.2.2020.

4.2.2020.

ellaOne

Laboratoire HRA Pharma

200 avenue de Pariz, 92320 Chatillon, France

EU/1/09/522

6.2.2020.

4.2.2020.

Ivabradin Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/17/1190

6.2.2020.

4.2.2020.

Lacosamide Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/17/1230

6.2.2020.

4.2.2020.

LIFMIOR

Pfizer Europe MA EEIG

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

EU/1/16/1165

6.2.2020.

4.2.2020.

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

6.2.2020.

4.2.2020.

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

6.2.2020.

4.2.2020.

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, Ireland

EU/1/06/359

6.2.2020.

4.2.2020.

Ucedane

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/17/1202

6.2.2020.

4.2.2020.

Ziagen

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/99/112

6.2.2020.

4.2.2020.

Zoely

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

EU/1/11/690

6.2.2020.

6.2.2020.

Aranesp

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185

10.2.2020.

6.2.2020.

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

EU/1/12/760

10.2.2020.

6.2.2020.

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

10.2.2020.

6.2.2020.

Granpidam

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/16/1137

10.2.2020.

6.2.2020.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

10.2.2020.

6.2.2020.

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

10.2.2020.

6.2.2020.

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

10.2.2020.

6.2.2020.

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

10.2.2020.

10.2.2020.

Inhixa

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

EU/1/16/1132

12.2.2020.

11.2.2020.

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/290

13.2.2020.

11.2.2020.

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

13.2.2020.

11.2.2020.

Entecavir Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/17/1211

13.2.2020.

11.2.2020.

OCALIVA

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

13.2.2020.

11.2.2020.

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/15/1059

13.2.2020.

11.2.2020.

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/16/1115

13.2.2020.

11.2.2020.

Rebetol

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/107

13.2.2020.

11.2.2020.

Symkevi

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/18/1306

13.2.2020.

11.2.2020.

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/114

13.2.2020.

11.2.2020.

Zevalin

Ceft Biopharma s.r.o

Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika

EU/1/03/264

13.2.2020.

12.2.2020.

Zoledronic acid Hospira

Pfizer Europe MA EEIG

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

EU/1/12/800

14.2.2020.

13.2.2020.

Aimovig

Novartis Europharm Limited

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

EU/1/18/1293

17.2.2020.

13.2.2020.

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

17.2.2020.

13.2.2020.

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

17.2.2020.

13.2.2020.

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/11/733

17.2.2020.

13.2.2020.

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1010

17.2.2020.

13.2.2020.

Ebixa

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/02/219

17.2.2020.

13.2.2020.

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

17.2.2020.

13.2.2020.

Mvasi

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

17.2.2020.

13.2.2020.

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

17.2.2020.

13.2.2020.

Sprycel

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/06/363

17.2.2020.

13.2.2020.

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

17.2.2020.

13.2.2020.

Ventavis

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/255

17.2.2020.

17.2.2020.

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

19.2.2020.

17.2.2020.

Atripla

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/07/430

19.2.2020.

17.2.2020.

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/11/691

19.2.2020.

17.2.2020.

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

19.2.2020.

17.2.2020.

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/16/1157

19.2.2020.

17.2.2020.

Tacforius

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

2.3.2020.

17.2.2020.

Vyndaqel

Pfizer Europe MA EEIG

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

EU/1/11/717

19.2.2020.

18.2.2020.

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

20.2.2020.

21.2.2020.

Cholib

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/13/866

25.2.2020.

21.2.2020.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

25.2.2020.

21.2.2020.

Docetaxel Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/769

25.2.2020.

21.2.2020.

Eptifibatid Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/15/1065

25.2.2020.

21.2.2020.

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

25.2.2020.

21.2.2020.

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

18.2.2020.

21.2.2020.

Lyrica

Pfizer Europe MA EEIG

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

EU/1/04/279

25.2.2020.

21.2.2020.

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

25.2.2020.

21.2.2020.

Resolor

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

EU/1/09/581

25.2.2020.

21.2.2020.

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/17/1236

25.2.2020.

21.2.2020.

Voriconazole Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/13/835

25.2.2020.

21.2.2020.

Zalasta

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415

25.2.2020.

21.2.2020.

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

25.2.2020.

21.2.2020.

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

25.2.2020.

24.2.2020.

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/12/770

26.2.2020.

24.2.2020.

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

26.2.2020.

24.2.2020.

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Pariz, France

EU/1/18/1318

26.2.2020.

25.2.2020.

Aripiprazole Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1005

27.2.2020.

28.2.2020.

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/07/387

3.3.2020.

28.2.2020.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

3.3.2020.

28.2.2020.

Cuprymina

A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.

Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia

EU/1/12/784

3.3.2020.

28.2.2020.

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland

EU/1/15/1008

3.3.2020.

28.2.2020.

Januvia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/383

3.3.2020.

28.2.2020.

Ledaga

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

3.3.2020.

28.2.2020.

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/09/523

3.3.2020.

28.2.2020.

Pegfilgrastim Mundipharma

Mundipharma Corporation (Ireland) Limited

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

EU/1/19/1409

3.3.2020.

28.2.2020.

Pemetrexed Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España

EU/1/15/1071

3.3.2020.

28.2.2020.

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

3.3.2020.

28.2.2020.

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

3.3.2020.

28.2.2020.

Voncento

CSL Behring GmbH

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

EU/1/13/857

3.3.2020.

28.2.2020.

Xerava

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/18/1312

3.3.2020.

28.2.2020.

Xeristar

Esteve Pharmaceuticals S.A.

Passeig de la Zona Franca, 109, 08038 Barcelona, España

EU/1/04/297

3.3.2020.

28.2.2020.

Xolair

Novartis Europharm Limited

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

EU/1/05/319

3.3.2020.

28.2.2020.

Zoledronic acid Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/13/834

3.3.2020.

28.2.2020.

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

3.3.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 11.2.2020. | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 13.2.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

11.2.2020.

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

13.2.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 4.2.2020. | Clevor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/17/222 | 6.2.2020. |
| 11.2.2020. | Halagon | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | EU/2/16/201 | 13.2.2020. |
| 11.2.2020. | Meloxidyl | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | EU/2/06/070 | 13.2.2020. |
| 11.2.2020. | Oxyglobin | OPK Biotech Netherlands BV
  Teleportboulevard 140, 1043 EJ Amsterdam, Nederland | EU/2/99/015 | 14.2.2020. |
| 11.2.2020. | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 13.2.2020. |
| 17.2.2020. | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 19.2.2020. |
| 17.2.2020. | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 19.2.2020. |
| 18.2.2020. | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | EU/2/11/128 | 20.2.2020. |
| 18.2.2020. | Zycortal | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | EU/2/15/189 | 20.2.2020. |
| 26.2.2020. | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/141 | 28.2.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.2.2020.

Clevor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

6.2.2020.

11.2.2020.

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/16/201

13.2.2020.

11.2.2020.

Meloxidyl

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/06/070

13.2.2020.

11.2.2020.

Oxyglobin

OPK Biotech Netherlands BV

Teleportboulevard 140, 1043 EJ Amsterdam, Nederland

EU/2/99/015

14.2.2020.

11.2.2020.

Palladia

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/09/100

13.2.2020.

17.2.2020.

Zulvac 1 Bovis

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/130

19.2.2020.

17.2.2020.

Zulvac 1 Ovis

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/131

19.2.2020.

18.2.2020.

Emdocam

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

20.2.2020.

18.2.2020.

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/15/189

20.2.2020.

26.2.2020.

Porcilis ColiClos

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/141

28.2.2020.

—   Povlačenje odobrenja za stavljanje u promet (članak 38. 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 |
| --- | --- | --- | --- | --- |
| 18.2.2020. | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 20.2.2020. |
| 18.2.2020. | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 20.2.2020. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

18.2.2020.

Zulvac 1 Bovis

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/130

20.2.2020.

18.2.2020.

Zulvac 1 Ovis

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/11/131

20.2.2020.

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

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