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226 results
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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: Zavicefta
ceftazidime / avibactam, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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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: Calquence
acalabrutinib, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: HyQvia
human normal immunoglobulin, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Rozlytrek
entrectinib, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Olumiant
baricitinib, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Zavicefta
ceftazidime / avibactam, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Flucelvax Tetra
influenza vaccine surface antigen inactivated prepared in cell cultures, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Zejula
niraparib, 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: Symkevi
tezacaftor / ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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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: Obiltoxaximab SFL
obiltoxaximab, 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: 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: Dupixent
dupilumab, 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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Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amNide for: Treatment of microscopic polyangiitis (avacopan) (updated)
Date of first decision: 19/11/2014, Positive, Last updated: 15/10/2020 -
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Orphan designation: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide (avacopan) for: Treatment of granulomatosis with polyangiitis (updated)
Date of first decision: 19/11/2014, Positive, Last updated: 15/10/2020 -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of first decision: 23/04/2012, Positive, Last updated: 22/09/2020 -
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Orphan designation: Obiltoxaximab for: Treatment of anthrax
Date of first decision: 24/08/2018, Positive, Last updated: 18/09/2020