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433 results
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Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Quofenix
delafloxacin, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Benlysta
belimumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Summary of opinion: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Venclyxto (new)
venetoclax, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Abiraterone Krka (new)
abiraterone acetate, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Celsunax (new)
ioflupane (123I), opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Tagrisso (new)
osimertinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Koselugo (new)
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Enspryng (new)
satralizumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Maviret (new)
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
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Summary of opinion: Cabometyx
cabozantinib, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Orphan designation: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor for: Treatment of cystic fibrosis (updated)
Date of first decision: 14/12/2018, Positive, Last updated: 06/05/2021 -
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Orphan designation: Risdiplam for: Treatment of spinal muscular atrophy (updated)
Date of first decision: 26/02/2019, Positive, Last updated: 04/05/2021 -
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Orphan designation: pemigatinib for: Treatment of biliary tract cancer (updated)
Date of first decision: 24/08/2018, Positive, Last updated: 04/05/2021 -
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Orphan designation: Cannabidiol for: Treatment of tuberous sclerosis (updated)
Date of first decision: 17/01/2018, Positive, Last updated: 26/04/2021 -
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Orphan designation: Somapacitan for: Treatment of growth hormone deficiency
Date of first decision: 24/08/2018, Positive, Last updated: 15/04/2021 -
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Orphan designation: Murine anti-CD22 antibody variable region fused to truncated Pseudomonas exotoxin 38 ( Moxetumomab pasudotox) for: Treatment of hairy cell leukaemia
Date of first decision: 05/12/2008, Positive, Last updated: 09/03/2021 -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-polycythaemia vera myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021 -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of first decision: 26/11/2010, Positive, Last updated: 03/03/2021