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140 results
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Summary of opinion: Meloxoral
meloxicam, opinion date: 06/10/2022, Positive, Last updated: 07/10/2022 -
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Summary of opinion: Melovem
meloxicam, opinion date: 20/04/2023, Positive, Last updated: 21/04/2023 -
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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: Ronapreve
casirivimab, imdevimab, 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: Ryeqo
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Jemperli
dostarlimab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Veyvondi
vonicog alfa, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Brukinsa
zanubrutinib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Fluad Tetra (new)
influenza vaccine (surface antigen, inactivated, adjuvanted), opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Azacitidine Kabi (new)
azacitidine, opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Naveruclif (new)
paclitaxel, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Talzenna (new)
talazoparib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: NexoBrid (new)
concentrate of proteolytic enzymes enriched in bromelain, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Ayvakyt (new)
avapritinib, 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: 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: 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 -
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Orphan designation: Cyclic pyranopterin monophosphate (fosdenopterin) for: Treatment of molybdenum-cofactor deficiency type A
Date of designation: 20/09/2010, Positive, Last updated: 17/07/2023