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34 results
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Summary of opinion: Translarna
ataluren, opinion date: 27/06/2019, Negative, Last updated: 18/10/2019 -
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Summary of opinion: Trelegy Ellipta
fluticasone furoate / umeclidinium / vilanterol, opinion date: 20/09/2018, Positive, Last updated: 21/09/2018 -
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Summary of opinion: Venclyxto
venetoclax, opinion date: 20/09/2018, Positive, Last updated: 21/09/2018 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 26/07/2018, Positive, Last updated: 27/07/2018 -
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Summary of opinion: Symkevi
tezacaftor / ivacaftor, opinion date: 26/07/2018, Positive, Last updated: 27/07/2018 -
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Summary of opinion: Rubraca
rucaparib, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Hemlibra
emicizumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Summary of opinion: Grasustek
pegfilgrastim, opinion date: 26/04/2019, Positive, Last updated: 26/04/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 27/06/2019, Positive, Last updated: 28/06/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 25/07/2019, Positive, Last updated: 26/07/2019 -
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Summary of opinion: Macimorelin Aeterna Zentaris
macimorelin, opinion date: 15/11/2018, Positive, Last updated: 16/11/2018 -
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Summary of opinion: Revlimid
lenalidomide, opinion date: 14/11/2019, Positive, Last updated: 15/11/2019 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Ervebo
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Evotaz
atazanavir / cobicistat, opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 27/06/2019, Positive, Last updated: 28/06/2019 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 19/09/2019, Positive, Last updated: 20/09/2019 -
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Referral: Xeljanz (updated)
tofacitinib, ?> associated names: Xeljanz, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 14/11/2019, Last updated: 15/11/2019 -
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Referral: Lartruvo
olaratumab, ?> associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan and olmesartan, ?> associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 02/04/2019, Last updated: 20/08/2019 -
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Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, ?> associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 19/03/2019 -
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Referral: Xofigo
radium Ra223 dichloride, ?> associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, -
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Referral: Zinbryta
daclizumab, ?> associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018,