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118 results
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Summary of opinion: Venclyxto
venetoclax, opinion date: 20/09/2018, Positive, Last updated: 21/09/2018 -
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Summary of opinion: Trelegy Ellipta
fluticasone furoate / umeclidinium / vilanterol, opinion date: 20/09/2018, Positive, Last updated: 21/09/2018 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 26/07/2018, Positive, Last updated: 27/07/2018 -
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Summary of opinion: Symkevi
tezacaftor / ivacaftor, opinion date: 26/07/2018, Positive, Last updated: 27/07/2018 -
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Summary of opinion: Repatha
evolocumab, opinion date: 22/03/2018, Positive, Last updated: 23/03/2018 -
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Summary of opinion: Praluent
alirocumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Summary of opinion: Macimorelin Aeterna Zentaris
macimorelin, opinion date: 15/11/2018, Positive, Last updated: 16/11/2018 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 01/03/2019, Positive, Last updated: 01/03/2019 -
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Summary of opinion: Rubraca
rucaparib, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Lynparza
olaparib, opinion date: 01/03/2019, Positive, Last updated: 01/03/2019 -
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Summary of opinion: Lynparza
olaparib, opinion date: 26/04/2019, Positive, Last updated: 26/04/2019 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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Summary of opinion: Hemlibra
emicizumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Orphan designation: Pomalidomide for: Treatment of multiple myeloma (updated)
Date of first decision: 08/10/2009, Positive, Last updated: 18/06/2019 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for: Treatment of beta thalassaemia intermedia and major (updated)
Date of first decision: 24/01/2013, Positive, Last updated: 03/06/2019 -
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Orphan designation: Pegylated recombinant phenylalanine ammonia lyase (pegvaliase) for: Treatment of hyperphenylalaninaemia (updated)
Date of first decision: 28/01/2010, Positive, Last updated: 29/05/2019 -
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Orphan designation: Isavuconazonium sulfate for: Treatment of mucormycosis (updated)
Date of first decision: 04/06/2014, Positive, Last updated: 21/05/2019 -
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Orphan designation: Isavuconazonium sulfate for: Treatment of invasive aspergillosis (updated)
Date of first decision: 04/07/2014, Positive, Last updated: 21/05/2019 -
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Orphan designation: 1-Deoxygalactonojirimycin hydrochloride for: Treatment of Fabry disease (updated)
Date of first decision: 22/05/2006, Positive, Last updated: 21/05/2019 -
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Orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (volanesorsen) for: Treatment of familial chylomicronaemia syndrome (updated)
Date of first decision: 19/02/2014, Positive, Last updated: 20/05/2019 -
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Orphan designation: Phosphorothioate oligonucleotide targeted to transthyretin (inotersen) for: Treatment of ATTR amyloidosis
Date of first decision: 26/03/2014, Positive, Last updated: 17/05/2019 -
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Orphan designation: Human coagulation factor X for: Treatment of hereditary factor X deficiency
Date of first decision: 14/09/2007, Positive, Last updated: 26/03/2019 -
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Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for: Treatment of retinitis pigmentosa
Date of first decision: 28/07/2015, Positive, Last updated: 04/03/2019 -
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Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for: Treatment of leber's congenital amaurosis
Date of first decision: 02/04/2012, Positive, Last updated: 04/03/2019