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228 results
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Summary of opinion: Elzonris (updated)
tagraxofusp, opinion date: 23/07/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Deltyba
delamanid, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Blincyto
blinatumomab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Tremfya
guselkumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Desloratadine ratiopharm
desloratadine, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Lenalidomide Mylan
lenalidomide, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Tecartus
opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Libmeldy
opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Fintepla
opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Obiltoxaximab SFL
opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Recarbrio
imipenem, cilastatin, relebactam, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Crysvita
burosumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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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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Summary of opinion: Symkevi
tezacaftor, ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kyprolis
carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Zavicefta
ceftazidime, avibactam, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020 -
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Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020