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199 results
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Summary of opinion: Pretomanid FGK
pretomanid, opinion date: 26/03/2020, Positive, Last updated: 27/03/2020 -
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Summary of opinion: Apixaban Accord
apixaban, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
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Summary of opinion: Hepcludex
bulevirtide, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020 -
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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: Cablivi
caplacizumab, 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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Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells for: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns (updated)
Date of first decision: 07/11/2008, Positive, Last updated: 23/06/2020 -
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Orphan designation: Beclomethasone 17, 21-dipropionate (oral use) (beclometasone dipropionate) for: Treatment of intestinal graft-versus-host disease (updated)
Date of first decision: 13/03/2002, Positive, Last updated: 08/06/2020 -
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Orphan designation: pasireotide for: Treatment of acromegaly
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
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 -
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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