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274 results
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Summary of opinion: Sohonos
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 13/02/2023 -
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Summary of opinion: Pombiliti
cipaglucosidase alfa, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022 -
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Summary of opinion: Trecondi
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Wakix
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dapagliflozin Viatris
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Tibsovo
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Elfabrio
pegunigalsidase alfa, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Lacosamide Adroiq (new)
lacosamide, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Sugammadex Adroiq (new)
sugammadex, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Dabigatran Etexilate Accord (new)
dabigatran etexilate, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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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 designation: 29/07/2014, Positive, Last updated: 21/03/2023 -
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Orphan designation: Panobinostat for: Treatment of multiple myeloma (updated)
Date of designation: 08/11/2012, Positive, Last updated: 13/03/2023 -
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Orphan designation: arimoclomol citrate for: Treatment of Niemann-Pick's disease, type C
Date of designation: 19/11/2014, Positive, Last updated: 01/03/2023 -
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Orphan designation: Treprostinil sodium for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 14/04/2004, Positive, Last updated: 13/02/2023 -
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Orphan designation: Fenfluramine hydrochloride for: Treatment of Lennox-Gastaut syndrome
Date of designation: 27/02/2017, Positive, Last updated: 07/02/2023 -
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Orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III (volanesorsen) for: Treatment of familial chylomicronaemia syndrome
Date of designation: 19/02/2014, Positive, Last updated: 02/02/2023 -
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Orphan designation: Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel) for: Treatment of post-transplantation lymphoproliferative disorders
Date of designation: 21/03/2016, Positive, Last updated: 30/01/2023