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202 results
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Summary of opinion: Tulissin
tulathromycin, opinion date: 20/02/2020, Positive, Last updated: 21/02/2020 -
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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: Tulaven
tulathromycin, opinion date: 20/02/2020, Positive, Last updated: 21/02/2020 -
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Summary of opinion: Lydaxx
tulathromycin, opinion date: 18/03/2020, Positive, Last updated: 20/03/2020 -
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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: Darzalex
daratumumab, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Fingolimod Accord
fingolimod, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Carmustine Obvius
carmustine, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Cablivi
caplacizumab, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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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: pasireotide for: Treatment of acromegaly (updated)
Date of first decision: 08/10/2009, Positive, Last updated: 13/05/2020 -
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Orphan designation: pasireotide for: Treatment of Cushing's disease (updated)
Date of first decision: 08/10/2009, Positive, Last updated: 13/05/2020 -
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Orphan designation: Treprostinil sodium for: Treatment of chronic thromboembolic pulmonary hypertension
Date of first decision: 08/02/2013, Positive, Last updated: 08/04/2020 -
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Orphan designation: Mepolizumab for: Treatment of hypereosinophilic syndrome
Date of first decision: 29/07/2004, Positive, Last updated: 07/04/2020 -
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Orphan designation: Metreleptin for: Treatment of familial partial lipodystrophy
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
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
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
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
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
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
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