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274 results
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Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 12/10/2023, Negative, Last updated: 13/10/2023 -
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Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Yorvipath
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Finlee
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Loargys
Pegzilarginase, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Rezzayo
rezafungin, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Spexotras (new)
trametinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Rimmyrah (new)
ranibizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Rystiggo (new)
Rozanolixizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Omjjara (new)
momelotinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Prevymis
letermovir, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Agamree
Vamorolone, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Uzpruvo (new)
ustekinumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Takhzyro
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Orphan designation: Talquetamab for: Treatment of multiple myeloma
Date of designation: 20/08/2021, Positive, Last updated: 21/09/2023 -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) for: Treatment of hypoparathyroidism
Date of designation: 19/10/2020, Positive, Last updated: 15/09/2023 -
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Orphan designation: Dabrafenib mesylate for: Treatment of glioma
Date of designation: 09/12/2020, Positive, Last updated: 15/09/2023 -
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Orphan designation: Ganaxolone for: Treatment of CDKL5 deficiency disorder
Date of designation: 13/11/2019, Positive, Last updated: 31/07/2023 -
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Orphan designation: edaravone for: Treatment of amyotrophic lateral sclerosis
Date of designation: 19/06/2015, Positive, Last updated: 21/07/2023 -
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Orphan designation: Glofitamab for: Treatment of diffuse large B-cell lymphoma
Date of designation: 15/10/2021, Positive, Last updated: 18/07/2023 -
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Orphan designation: Recombinant human acid sphingomyelinase (also known as olipudase alfa) for: Treatment of Niemann-Pick disease
Date of designation: 24/06/2022, Positive, Last updated: 18/07/2023 -
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Orphan designation: (1R,2R)-octanoic acid[2-(2',3'-dihydro-benzo[1,4] dioxin-6'-yl)-2-hydroxy-1-pyrrolidin-1-ylmethyl-ethyl]-amide-L-tartaric acid salt (eliglustat) for: Treatment of Gaucher disease
Date of designation: 04/12/2007, Positive, Last updated: 18/07/2023 -
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Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab) for: Treatment of autoimmune haemolytic anaemia
Date of designation: 17/02/2016, Positive, Last updated: 18/07/2023