13 results
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Summary of opinion: Sovaldi
sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Harvoni
ledispavir / sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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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: Ofev
nintedanib, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
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Summary of opinion: Ofev
nintedanib, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Idefirix
imlifidase, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Epclusa
sofosbuvir / velpatasvir, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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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: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020