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233 results
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Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
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Summary of opinion: Flynpovi
eflornithine, sulindac, opinion date: 24/06/2021, Negative, Last updated: 23/07/2021 -
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Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Deltyba
delamanid, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Brukinsa (new)
zanubrutinib, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Adempas (new)
riociguat, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Libmyris (new)
adalimumab, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Hukyndra (new)
adalimumab, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease (updated)
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
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Orphan designation: Recombinant human parathyroid hormone for: Treatment of hypoparathyroidism (updated)
Date of designation: 16/01/2014, Positive, Last updated: 24/09/2021 -
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Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for: Treatment of hereditary angioedema (updated)
Date of designation: 09/10/2015, Positive, Last updated: 20/09/2021 -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-polycythaemia vera myelofibrosis (updated)
Date of designation: 26/11/2010, Positive, Last updated: 17/09/2021 -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of post-essential thrombocythaemia myelofibrosis (updated)
Date of designation: 26/11/2010, Positive, Last updated: 17/09/2021 -
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Orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib) for: Treatment of primary myelofibrosis (updated)
Date of designation: 01/10/2010, Positive, Last updated: 17/09/2021 -
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Orphan designation: Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene for: Treatment of high-grade glioma with subsequent use of ganciclovir sodium (updated)
Date of designation: 06/02/2002, Positive, Last updated: 16/09/2021 -
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Orphan designation: autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel) for: Treatment of mantle cell lymphoma (updated)
Date of designation: 13/11/2019, Positive, Last updated: 15/09/2021 -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of primary mediastinal large B-cell lymphoma (updated)
Date of designation: 09/10/2015, Positive, Last updated: 15/09/2021 -
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Orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel) for: Treatment of diffuse large B-cell lymphoma (updated)
Date of designation: 16/12/2014, Positive, Last updated: 15/09/2021 -
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Orphan designation: Selumetinib for: Treatment of neurofibromatosis type 1 (updated)
Date of designation: 31/07/2018, Positive, Last updated: 15/09/2021 -
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia (updated)
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021 -
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Orphan designation: Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab) for: Treatment of diffuse large B-cell lymphoma (updated)
Date of designation: 15/01/2015, Positive, Last updated: 08/09/2021 -
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Orphan designation: proteolytic enzymes enriched in bromelain for: Treatment of partial deep dermal and full-thickness burns (updated)
Date of designation: 30/07/2002, Positive, Last updated: 08/09/2021 -
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Orphan designation: Chimeric monoclonal antibody against GD2 for: Treatment of neuroblastoma
Date of designation: 08/11/2012, Positive, Last updated: 26/08/2021 -
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Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) for: Treatment of Castleman's disease
Date of designation: 30/11/2007, Positive, Last updated: 26/08/2021