# Jurnalul Oficial C 101/27 m

| | ISSN 1977-1029 |
| --- | --- |
| Jurnalul Oficial
  al Uniunii Europene | C 101 |
| | |
| Ediţia în limba română | Comunicări şi informări | Anul 6327 martie 2020 |

ISSN 1977-1029

Jurnalul Oficial

al Uniunii Europene

C 101

Ediţia în limba română

Comunicări şi informări

Anul 6327 martie 2020

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| Cuprins | Pagina |
| --- | --- |
| | IV   Informări |
| | INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE |
| | Comisia Europeană |
| 2020/C 101/01 | Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2020 până la 29 februarie 2020[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] | 1 |

Cuprins

Pagina

IV   Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

2020/C 101/01

Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2020 până la 29 februarie 2020[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

1

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RO

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IV Informări

INFORMĂRI PROVENIND DE LA INSTITUŢIILE, ORGANELE ȘI ORGANISMELE UNIUNII EUROPENE

Comisia Europeană

| 27.3.2020 | RO | Jurnalul Oficial al Uniunii Europene | C 101/1 |
| --- | --- | --- | --- |

27.3.2020

RO

Jurnalul Oficial al Uniunii Europene

C 101/1

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Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 februarie 2020 până la 29 februarie 2020

[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]

(2020/C 101/01)

—   Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | DCI (Denumirea Comună Internațională) | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Formă farmaceutică | Codul ATC (Codul Anatomic-Terapeutic-Chimic) | Data notificării |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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 | Soluție injectabilă | L04AB04 | 17.2.2020 |
| 13.2.2020 | Azacitidine Accord | Azacitidină | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1413 | Pulbere pentru suspensie injectabilă | 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 | Soluție injectabilă | S01LA06 | 17.2.2020 |
| 13.2.2020 | Dexmedetomidine Accord | dexmedetomidină | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | EU/1/19/1418 | Concentrat pentru soluție perfuzabilă | N05CM18 | 17.2.2020 |
| 13.2.2020 | Recarbrio | imipenem/cilastatină/relebactam | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/19/1420 | Pulbere pentru soluție perfuzabilă | J01DH56 | 17.2.2020 |

Data deciziei

Denumirea medicamentului

DCI (Denumirea Comună Internațională)

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Formă farmaceutică

Codul ATC (Codul Anatomic-Terapeutic-Chimic)

Data notificării

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

Soluție injectabilă

L04AB04

17.2.2020

13.2.2020

Azacitidine Accord

Azacitidină

Accord Healthcare S.L.U.

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

EU/1/19/1413

Pulbere pentru suspensie injectabilă

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

Soluție injectabilă

S01LA06

17.2.2020

13.2.2020

Dexmedetomidine Accord

dexmedetomidină

Accord Healthcare S.L.U.

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

EU/1/19/1418

Concentrat pentru soluție perfuzabilă

N05CM18

17.2.2020

13.2.2020

Recarbrio

imipenem/cilastatină/relebactam

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1420

Pulbere pentru soluție perfuzabilă

J01DH56

17.2.2020

—   Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 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 Paris, 92320 Chatillon, France | EU/1/09/522 | 6.2.2020 |
| 4.2.2020 | Ivabradină 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 Paris, 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 | Eptifibatide 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 Paris, 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 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

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 Paris, 92320 Chatillon, France

EU/1/09/522

6.2.2020

4.2.2020

Ivabradină 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 Paris, 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

Eptifibatide 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 Paris, 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

—   Retragerea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 11.2.2020 | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 13.2.2020 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

11.2.2020

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

13.2.2020

—   Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 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 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

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

—   Retragerea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]

| Data deciziei | Denumirea medicamentului | Titularul autorizației de introducere pe piață | Numărul de înregistrare în Registrul comunitar | Data notificării |
| --- | --- | --- | --- | --- |
| 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 |

Data deciziei

Denumirea medicamentului

Titularul autorizației de introducere pe piață

Numărul de înregistrare în Registrul comunitar

Data notificării

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

Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

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(1)  JO L 136, 30.4.2004, p. 1.

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