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56 results
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Summary of opinion: Bluevac BTV8
opinion date: 18/06/2020, Positive, Last updated: 19/06/2020 -
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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: Tulinovet
tulathromycin, opinion date: 16/07/2020, Positive, Last updated: 17/07/2020 -
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Summary of opinion: Increxxa
tulathromycin, opinion date: 16/07/2020, Positive, Last updated: 17/07/2020 -
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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: Kalydeco
ivacaftor, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Rivaroxaban Accord
rivaroxaban, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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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: Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Desloratadine ratiopharm
desloratadine, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Tecartus
autologous anti-CD19-transduced CD3+ cells, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Lenalidomide Mylan
lenalidomide, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome (updated)
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: 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 -
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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
Date of first decision: 07/11/2008, Positive, Last updated: 23/06/2020 -
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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: 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