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111 results
Medicine type
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Summary of opinion: Deltyba
delamanid, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Blincyto
blinatumomab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Tremfya
guselkumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Recarbrio
imipenem, cilastatin, relebactam, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Crysvita
burosumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Epclusa
sofosbuvir, velpatasvir, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Symkevi
tezacaftor, ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kyprolis
carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Zavicefta
ceftazidime, avibactam, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Orphan designation: Obiltoxaximab for: Treatment of anthrax (updated)
Date of first decision: 24/08/2018, Positive, Last updated: 27/11/2020 -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (lumasiran) for: Treatment of primary hyperoxaluria (updated)
Date of first decision: 21/03/2016, Positive, Last updated: 25/11/2020 -
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Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) for: Treatment of sickle cell disease (updated)
Date of first decision: 09/08/2012, Positive, Last updated: 24/11/2020 -
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Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa) for: Treatment of mucopolysaccharidosis type VII (Sly syndrome) (updated)
Date of first decision: 21/03/2012, Positive, Last updated: 11/11/2020 -
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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 (updated)
Date of first decision: 04/08/2010, Positive, Last updated: 06/11/2020 -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of first decision: 23/04/2012, Positive, Last updated: 22/09/2020 -
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Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for: Treatment of multiple myeloma
Date of first decision: 16/10/2017, Positive, Last updated: 17/09/2020 -
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Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase) for: Prevention of graft rejection following solid organ transplantation
Date of first decision: 12/01/2017, Positive, Last updated: 28/08/2020 -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Adjunctive treatment in haematopoietic cell transplantation
Date of first decision: 15/01/2009, Positive, Last updated: 26/08/2020 -
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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: 26/08/2020 -
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Orphan designation: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (darvadstrocel) for: Treatment of anal fistula
Date of first decision: 08/10/2009, Positive, Last updated: 26/08/2020 -
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Orphan designation: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 11/01/2012, Positive, Last updated: 26/08/2020 -
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Orphan designation: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid for: Treatment of multiple myeloma
Date of first decision: 27/09/2011, Positive, Last updated: 26/08/2020