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117 results
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Summary of opinion: Translarna
ataluren, opinion date: 27/06/2019, Negative, Last updated: 18/10/2019 -
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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: Venclyxto
venetoclax, 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: Rubraca
rucaparib, opinion date: 13/12/2018, Positive, Last updated: 14/12/2018 -
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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: Grasustek
pegfilgrastim, opinion date: 26/04/2019, Positive, Last updated: 26/04/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 31/01/2019, Positive, Last updated: 01/02/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 27/06/2019, Positive, Last updated: 28/06/2019 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 25/07/2019, Positive, Last updated: 26/07/2019 -
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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: Revlimid
lenalidomide, opinion date: 14/11/2019, Positive, Last updated: 15/11/2019 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Ervebo
Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Evotaz
atazanavir / cobicistat, opinion date: 17/10/2019, Positive, Last updated: 18/10/2019 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 27/06/2019, Positive, Last updated: 28/06/2019 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 19/09/2019, Positive, Last updated: 20/09/2019 -
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Orphan designation: for: Treatment of hypophosphatasia (updated)
Date of first decision: 04/12/2008, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of lysosomal acid lipase deficiency (updated)
Date of first decision: 17/12/2010, Positive, Last updated: 20/11/2019 -
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Orphan designation: for: Treatment of acute myeloid leukaemia (updated)
Date of first decision: 17/01/2018, Positive, Last updated: 08/11/2019 -
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Orphan designation: for: Treatment of hyperargininaemia
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019 -
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Orphan designation: for: Ornithine translocase deficiency (hyperornithinaemia-hyperammonaemia homocitrullinuria (HHH) syndrom
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019 -
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Orphan designation: for: Treatment of argininosuccinic aciduria
Date of first decision: 10/06/2010, Positive, Last updated: 12/07/2019