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430 results
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Summary of opinion: Pemazyre (updated)
pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Spravato
esketamine, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Thiotepa Riemser
thiotepa, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Sogroya
somapacitan, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Nexpovio
selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Keytruda
pembrolizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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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: Tysabri
natalizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Vaxchora
Cholera vaccine (recombinant, live, oral), opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Evrysdi
risdiplam, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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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: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Abiraterone Accord
abiraterone, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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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: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Orladeyo
berotralstat, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Sarclisa
isatuximab, 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: Epidyolex
cannabidiol, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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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 (updated)
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 (updated)
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 primary myelofibrosis (updated)
Date of first decision: 01/10/2010, Positive, Last updated: 03/03/2021 -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major (updated)
Date of first decision: 29/07/2014, Positive, Last updated: 18/02/2021