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200 results
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Summary of opinion: Alunbrig
brigatinib, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
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Summary of opinion: Trepulmix
treprostinil sodium, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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Summary of opinion: Emgality
galcanezumab, opinion date: 27/02/2020, Negative, Last updated: 28/02/2020 -
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Summary of opinion: Venclyxto
venetoclax, opinion date: 30/01/2020, Positive, Last updated: 31/01/2020 -
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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: Jorveza
budesonide, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
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Summary of opinion: Ofev
nintedanib, opinion date: 27/02/2020, Positive, Last updated: 28/02/2020 -
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Orphan designation: Metreleptin for: Treatment of familial partial lipodystrophy (updated)
Date of first decision: 17/07/2012, Positive, Last updated: 02/04/2020 -
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Orphan designation: Metreleptin for: Treatment of Barraquer-Simons syndrome (updated)
Date of first decision: 17/07/2012, Positive, Last updated: 02/04/2020 -
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Orphan designation: Metreleptin for: Treatment of Lawrence syndrome (updated)
Date of first decision: 17/07/2012, Positive, Last updated: 02/04/2020 -
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Orphan designation: Metreleptin for: Treatment of Berardinelli-Seip syndrome (updated)
Date of first decision: 17/07/2012, Positive, Last updated: 02/04/2020 -
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Orphan designation: Carboxypeptidase G2 for: Adjunctive treatment in patients at risk of methotrexate toxicity (updated)
Date of first decision: 03/02/2003, Positive, Last updated: 02/04/2020 -
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Orphan designation: Osilodrostat for: Treatment of Cushing's syndrome (updated)
Date of first decision: 15/10/2014, Positive, Last updated: 26/03/2020 -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA, covalently linked to a ligand containing three N-acetylgalactosamine residues (givosiran) for: Treatment of acute hepatic porphyria (updated)
Date of first decision: 29/08/2016, Positive, Last updated: 09/03/2020 -
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Orphan designation: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate (tafamidis) for: Treatment of familial amyloid polyneuropathy
Date of first decision: 28/08/2006, Positive, Last updated: 25/02/2020 -
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Orphan designation: tafamidis for: Treatment of senile systemic amyloidosis
Date of first decision: 08/11/2012, Positive, Last updated: 25/02/2020 -
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Orphan designation: polatuzumab vedotin for: Treatment of diffuse large B-cell lymphoma
Date of first decision: 16/04/2018, Positive, Last updated: 27/01/2020 -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for: Treatment of peripheral T-cell lymphoma
Date of first decision: 21/09/2019, Positive, Last updated: 16/01/2020 -
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Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (niraparib) for: Treatment of ovarian cancer
Date of first decision: 04/08/2010, Positive, Last updated: 18/12/2019 -
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Orphan designation: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein for: Treatment of hypophosphatasia
Date of first decision: 04/12/2008, Positive, Last updated: 20/11/2019 -
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Orphan designation: Recombinant human lysosomal acid lipase for: Treatment of lysosomal acid lipase deficiency
Date of first decision: 17/12/2010, Positive, Last updated: 20/11/2019 -
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Orphan designation: Eculizumab for: Treatment myasthenia gravis
Date of first decision: 29/07/2014, Positive, Last updated: 20/11/2019 -
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Orphan designation: Eculizumab for: Treatment of neuromyelitis optica spectrum disorders
Date of first decision: 05/08/2013, Positive, Last updated: 20/11/2019 -
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Orphan designation: Eculizumab for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of first decision: 24/07/2009, Positive, Last updated: 20/11/2019