ISSN 1977-1010
Jornal Oficial
da União Europeia
C 309
Edição em língua portuguesa
Comunicações e Informações
61.° ano
31 de agosto de 2018
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ISSN 1977-1010 |
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Jornal Oficial da União Europeia |
C 309 |
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Edição em língua portuguesa |
Comunicações e Informações |
61.° ano |
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Índice |
Página |
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IV Informações |
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INFORMAÇÕES DAS INSTITUIÇÕES, ÓRGÃOS E ORGANISMOS DA UNIÃO EUROPEIA |
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Comissão Europeia |
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2018/C 309/01 |
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PT |
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IV Informações
INFORMAÇÕES DAS INSTITUIÇÕES, ÓRGÃOS E ORGANISMOS DA UNIÃO EUROPEIA
Comissão Europeia
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31.8.2018 |
PT |
Jornal Oficial da União Europeia |
C 309/1 |
Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de julho de 2018 a 31 de julho de 2018
[Publicado nos termos do artigo 13.o ou do artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho (1)]
(2018/C 309/01)
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— |
Concessão de uma autorização de introdução no mercado [artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado |
|
Data da decisão |
Nome do medicamento |
DCI (Denominação Comum Internacional) |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Forma farmacêutica |
Código ATC (código anatómico-terapêutico-químico) |
Data de notificação |
|
6.7.2018 |
Tegsedi |
inotersen |
IONIS USA Limited Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom |
EU/1/18/1296 |
Solução injectável |
Pending |
10.7.2018 |
|
6.7.2018 |
Verkazia |
Ciclosporina |
Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi |
EU/1/17/1219 |
Colírio, emulsão |
S01XA18 |
10.7.2018 |
|
26.7.2018 |
Aimovig |
erenumab |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/18/1293 |
Solução injectável |
N02C |
30.7.2018 |
|
26.7.2018 |
Halimatoz |
adalimumab |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1288 |
Solução injectável |
L04AB04 |
30.7.2018 |
|
26.7.2018 |
Hefiya |
adalimumab |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1287 |
Solução injectável |
L04AB04 |
30.7.2018 |
|
26.7.2018 |
Hyrimoz |
adalimumab |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/18/1286 |
Solução injectável |
L04AB04 |
30.7.2018 |
|
26.7.2018 |
Nityr |
nitisinona |
Cycle Pharmaceuticals Ltd Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom |
EU/1/18/1290 |
Comprimido |
A16AX04 |
30.7.2018 |
|
26.7.2018 |
RXULTI |
Brexpiprazol |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/18/1294 |
Comprimido revestido por película |
N05AX16 |
30.7.2018 |
|
26.7.2018 |
Trazimera |
trastuzumab |
Pfizer Europe MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/18/1295 |
Pó para concentrado para solução para perfusão |
L01XC03 |
30.7.2018 |
|
30.7.2018 |
Myalepta |
metreleptina |
Aegerion Pharmaceuticals B.V. Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland |
EU/1/18/1276 |
Pó para solução injectável |
A16AA07 |
1.8.2018 |
|
— |
Concessão de uma autorização de introdução no mercado [artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Recusado |
|
Data da decisão |
Nome do medicamento |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Data de notificação |
|
17.7.2018 |
Aplidin |
Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |
— |
19.7.2018 |
|
26.7.2018 |
Alsitek |
AB Science 3 avenue George V, 75008 Paris, France |
— |
30.7.2018 |
|
— |
Alteração de uma autorização de introdução no mercado [artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado |
|
Data da decisão |
Nome do medicamento |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Data de notificação |
|
2.7.2018 |
Bavencio |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/17/1214 |
4.7.2018 |
|
2.7.2018 |
CONTROLOC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/515 |
4.7.2018 |
|
2.7.2018 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
4.7.2018 |
|
2.7.2018 |
Docetaxel Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/769 |
4.7.2018 |
|
2.7.2018 |
Enurev Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/789 |
4.7.2018 |
|
2.7.2018 |
Ifirmacombi |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/11/673 |
4.7.2018 |
|
2.7.2018 |
Lemtrada |
Genzyme Therapeutics Ltd 4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom |
EU/1/13/869 |
4.7.2018 |
|
2.7.2018 |
Mysimba |
Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland |
EU/1/14/988 |
4.7.2018 |
|
2.7.2018 |
PANTOZOL Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/517 |
4.7.2018 |
|
2.7.2018 |
Prialt |
RIEMSER Pharma GmbH An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland |
EU/1/04/302 |
4.7.2018 |
|
2.7.2018 |
Simponi |
Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/09/546 |
4.7.2018 |
|
2.7.2018 |
SOMAC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/516 |
4.7.2018 |
|
2.7.2018 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/06/363 |
4.7.2018 |
|
2.7.2018 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
4.7.2018 |
|
2.7.2018 |
Trulicity |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/14/956 |
3.7.2018 |
|
2.7.2018 |
Xarelto |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/08/472 |
4.7.2018 |
|
6.7.2018 |
Adrovance |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/06/364 |
10.7.2018 |
|
6.7.2018 |
ALPROLIX |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/16/1098 |
10.7.2018 |
|
6.7.2018 |
Ammonaps |
Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige |
EU/1/99/120 |
10.7.2018 |
|
6.7.2018 |
Ariclaim |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/283 |
10.7.2018 |
|
6.7.2018 |
Corbilta |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/13/859 |
10.7.2018 |
|
6.7.2018 |
Fertavid |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/510 |
10.7.2018 |
|
6.7.2018 |
Hirobriz Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/594 |
10.7.2018 |
|
6.7.2018 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
10.7.2018 |
|
6.7.2018 |
Ninlaro |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/16/1094 |
10.7.2018 |
|
6.7.2018 |
Noxafil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/05/320 |
10.7.2018 |
|
6.7.2018 |
Pemetrexed Fresenius Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |
EU/1/16/1115 |
10.7.2018 |
|
6.7.2018 |
Pemetrexedo Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/15/1037 |
10.7.2018 |
|
6.7.2018 |
Praxbind |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1056 |
10.7.2018 |
|
6.7.2018 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/06/380 |
10.7.2018 |
|
6.7.2018 |
Puregon |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/96/008 |
10.7.2018 |
|
6.7.2018 |
Revolade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/10/612 |
10.7.2018 |
|
6.7.2018 |
Sovaldi |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/894 |
10.7.2018 |
|
6.7.2018 |
Symtuza |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1225 |
10.7.2018 |
|
6.7.2018 |
Tafinlar |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/865 |
10.7.2018 |
|
6.7.2018 |
Temozolomide HEXAL |
Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland |
EU/1/10/616 |
10.7.2018 |
|
6.7.2018 |
Temozolomide Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/10/617 |
10.7.2018 |
|
6.7.2018 |
Visudyne |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/00/140 |
10.7.2018 |
|
6.7.2018 |
Zykadia |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/15/999 |
10.7.2018 |
|
9.7.2018 |
Betaferon |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/95/003 |
11.7.2018 |
|
9.7.2018 |
Fosavance |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/05/310 |
11.7.2018 |
|
9.7.2018 |
MAVENCLAD |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/17/1212 |
11.7.2018 |
|
9.7.2018 |
Pylobactell |
Torbet Laboratories Limited Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom |
EU/1/98/064 |
11.7.2018 |
|
9.7.2018 |
Qutenza |
Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland |
EU/1/09/524 |
11.7.2018 |
|
9.7.2018 |
Seebri Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/788 |
11.7.2018 |
|
9.7.2018 |
Tovanor Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/12/790 |
11.7.2018 |
|
9.7.2018 |
Vantavo |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/09/572 |
11.7.2018 |
|
9.7.2018 |
Zavesca |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/238 |
11.7.2018 |
|
11.7.2018 |
Briviact |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/15/1073 |
13.7.2018 |
|
11.7.2018 |
Byetta |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/06/362 |
13.7.2018 |
|
11.7.2018 |
Erelzi |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich |
EU/1/17/1195 |
13.7.2018 |
|
11.7.2018 |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
13.7.2018 |
|
11.7.2018 |
Vizamyl |
GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom |
EU/1/14/941 |
13.7.2018 |
|
11.7.2018 |
Xagrid |
Shire Pharmaceutical Contracts Limited 1 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/04/295 |
13.7.2018 |
|
13.7.2018 |
Firdapse |
BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom |
EU/1/09/601 |
17.7.2018 |
|
13.7.2018 |
Karvea |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/97/049 |
17.7.2018 |
|
13.7.2018 |
Naglazyme |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland |
EU/1/05/324 |
17.7.2018 |
|
13.7.2018 |
Rebif |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/98/063 |
17.7.2018 |
|
19.7.2018 |
Dificlir |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/11/733 |
23.7.2018 |
|
19.7.2018 |
Irbesartan Zentiva |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/06/376 |
23.7.2018 |
|
19.7.2018 |
Lopinavir/Ritonavir Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1067 |
23.7.2018 |
|
19.7.2018 |
Optruma |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/98/074 |
23.7.2018 |
|
19.7.2018 |
PecFent |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/10/644 |
23.7.2018 |
|
19.7.2018 |
Plegridy |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |
EU/1/14/934 |
23.7.2018 |
|
19.7.2018 |
Qarziba |
EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom |
EU/1/17/1191 |
23.7.2018 |
|
19.7.2018 |
Rituzena |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/17/1206 |
23.7.2018 |
|
19.7.2018 |
SANCUSO |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/12/766 |
23.7.2018 |
|
19.7.2018 |
Translarna |
PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |
EU/1/13/902 |
23.7.2018 |
|
23.7.2018 |
Bemfola |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/13/909 |
25.7.2018 |
|
23.7.2018 |
Eperzan |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/13/908 |
25.7.2018 |
|
23.7.2018 |
Exjade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/06/356 |
25.7.2018 |
|
23.7.2018 |
Ivemend |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/07/437 |
25.7.2018 |
|
23.7.2018 |
Moventig |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/14/962 |
25.7.2018 |
|
23.7.2018 |
Parsabiv |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/16/1142 |
25.7.2018 |
|
23.7.2018 |
PREVYMIS |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/17/1245 |
25.7.2018 |
|
23.7.2018 |
Translarna |
PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland |
EU/1/13/902 |
25.7.2018 |
|
23.7.2018 |
Ultibro Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/862 |
25.7.2018 |
|
23.7.2018 |
Vargatef |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/954 |
25.7.2018 |
|
23.7.2018 |
Viread |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/01/200 |
25.7.2018 |
|
23.7.2018 |
Xoterna Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/863 |
25.7.2018 |
|
26.7.2018 |
Besponsa |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/17/1200 |
30.7.2018 |
|
26.7.2018 |
Ceplene |
Noventia Pharma Srl Via Carlo Pisacane 31, 47121 Forli, Italia |
EU/1/08/477 |
30.7.2018 |
|
26.7.2018 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország |
EU/1/12/750 |
30.7.2018 |
|
26.7.2018 |
Fareston |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/96/004 |
30.7.2018 |
|
26.7.2018 |
Genvoya |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/15/1061 |
30.7.2018 |
|
26.7.2018 |
Invokana |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/13/884 |
30.7.2018 |
|
26.7.2018 |
Jinarc |
Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
30.7.2018 |
|
26.7.2018 |
Lixiana |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/15/993 |
30.7.2018 |
|
26.7.2018 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/13/888 |
30.7.2018 |
|
26.7.2018 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
30.7.2018 |
|
26.7.2018 |
Procysbi |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/13/861 |
30.7.2018 |
|
26.7.2018 |
Rasagilina ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/14/977 |
30.7.2018 |
|
26.7.2018 |
Relvar Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/13/886 |
30.7.2018 |
|
26.7.2018 |
Revinty Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/929 |
30.7.2018 |
|
26.7.2018 |
Segluromet |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/18/1265 |
30.7.2018 |
|
26.7.2018 |
Trisenox |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/02/204 |
30.7.2018 |
|
26.7.2018 |
Tybost |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/13/872 |
30.7.2018 |
|
26.7.2018 |
Zalmoxis |
MolMed S.p.A. Via Olgettina 58, 20132 Milano, Italia |
EU/1/16/1121 |
30.7.2018 |
|
30.7.2018 |
Abraxane |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/07/428 |
1.8.2018 |
|
30.7.2018 |
Aprovel |
Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France |
EU/1/97/046 |
1.8.2018 |
|
30.7.2018 |
Arzerra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/625 |
1.8.2018 |
|
30.7.2018 |
Bridion |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/08/466 |
1.8.2018 |
|
30.7.2018 |
Champix |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/06/360 |
1.8.2018 |
|
30.7.2018 |
Cyanokit |
SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique /Louizalaan 480, 1050 Brussel, België |
EU/1/07/420 |
1.8.2018 |
|
30.7.2018 |
Enbrel |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/99/126 |
1.8.2018 |
|
30.7.2018 |
Eylea |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/12/797 |
1.8.2018 |
|
30.7.2018 |
Grastofil |
Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland |
EU/1/13/877 |
1.8.2018 |
|
30.7.2018 |
HALAVEN |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/11/678 |
1.8.2018 |
|
30.7.2018 |
IBRANCE |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/16/1147 |
1.8.2018 |
|
30.7.2018 |
Ilaris |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/09/564 |
1.8.2018 |
|
30.7.2018 |
Imlygic |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/15/1064 |
1.8.2018 |
|
30.7.2018 |
Inflectra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/13/854 |
1.8.2018 |
|
30.7.2018 |
Intelence |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/08/468 |
1.8.2018 |
|
30.7.2018 |
Lyrica |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/04/279 |
1.8.2018 |
|
30.7.2018 |
Mylotarg |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/18/1277 |
1.8.2018 |
|
30.7.2018 |
Nimenrix |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/12/767 |
1.8.2018 |
|
30.7.2018 |
NovoEight |
Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark |
EU/1/13/888 |
1.8.2018 |
|
30.7.2018 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
1.8.2018 |
|
30.7.2018 |
Pregabalina Pfizer |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/14/916 |
1.8.2018 |
|
30.7.2018 |
Revatio |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/05/318 |
1.8.2018 |
|
30.7.2018 |
Stocrin |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/99/111 |
1.8.2018 |
|
30.7.2018 |
Strimvelis |
GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland |
EU/1/16/1097 |
1.8.2018 |
|
30.7.2018 |
Temozolomide SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
EU/1/11/697 |
1.8.2018 |
|
30.7.2018 |
Temozolomide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/606 |
1.8.2018 |
|
30.7.2018 |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
1.8.2018 |
|
30.7.2018 |
Toviaz |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/07/386 |
1.8.2018 |
|
30.7.2018 |
Tygacil |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/06/336 |
1.8.2018 |
|
30.7.2018 |
Tyverb |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/440 |
1.8.2018 |
|
30.7.2018 |
Ucedane |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/17/1202 |
1.8.2018 |
|
30.7.2018 |
Viagra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/98/077 |
1.8.2018 |
|
30.7.2018 |
Vidaza |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/08/488 |
1.8.2018 |
|
— |
Retirada de uma autorização de introdução no mercado [artigo 13.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho] |
|
Data da decisão |
Nome do medicamento |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Data de notificação |
|
6.7.2018 |
DepoCyte |
Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom |
EU/1/01/187 |
10.7.2018 |
|
9.7.2018 |
Ariclaim |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/283 |
11.7.2018 |
|
19.7.2018 |
Trobalt |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/11/681 |
23.7.2018 |
|
— |
Concessão de uma autorização de introdução no mercado [artigo 38.o do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho]: Autorizado |
|
Data da decisão |
Nome do medicamento |
DCI (Denominação Comum Internacional) |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Forma farmacêutica |
Código ATC (código anatómico-terapêutico-químico) |
Data de notificação |
|
26.7.2018 |
UBAC |
Vacina (inativada)de Streptococcus uberis |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/18/227 |
Emulsão injectável |
QI02AB |
30.7.2018 |
|
— |
Alteração de uma autorização de introdução no mercado (Artigo 38 do Regulamento (CE) n.o 726/2004 do Parlamento Europeu e do Conselho): Autorizado |
|
Data da decisão |
Nome do medicamento |
Titular da autorização de introdução no mercado |
Número de inscrição no Registo Comunitário |
Data de notificação |
|
2.7.2018 |
ERYSENG PARVO |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/14/167 |
4.7.2018 |
|
2.7.2018 |
Zolvix |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/09/101 |
4.7.2018 |
|
5.7.2018 |
Pexion |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/12/147 |
9.7.2018 |
|
9.7.2018 |
Coliprotec F4/F18 |
Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland |
EU/2/16/202 |
11.7.2018 |
|
9.7.2018 |
Credelio |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/17/206 |
11.7.2018 |
|
9.7.2018 |
ERYSENG |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/14/166 |
11.7.2018 |
|
9.7.2018 |
Hiprabovis IBR Marker Live |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/10/114 |
11.7.2018 |
|
9.7.2018 |
Trocoxil |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/08/084 |
11.7.2018 |
|
10.7.2018 |
Econor |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/98/010 |
12.7.2018 |
|
12.7.2018 |
Procox |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/11/123 |
16.7.2018 |
|
13.7.2018 |
Reconcile |
Nexcyon Pharmaceuticals Ltd First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom |
EU/2/08/080 |
16.7.2018 |
|
23.7.2018 |
Nobivac L4 |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/12/143 |
25.7.2018 |
|
23.7.2018 |
Respiporc Flu3 |
IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland |
EU/2/09/103 |
25.7.2018 |
|
26.7.2018 |
Apoquel |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/13/154 |
30.7.2018 |
Os interessados podem solicitar o acesso ao relatório público dos medicamentos em questão e das decisões correspondentes junto de:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |