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53 results
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Summary of opinion: Sovaldi
sofosbuvir, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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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: Kalydeco
ivacaftor, opinion date: 30/04/2020, Positive, Last updated: 30/04/2020 -
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Summary of opinion: Livogiva
teriparatide, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Idefirix
imlifidase, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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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: Qutavina
teriparatide, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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Summary of opinion: Remsima
infliximab, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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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: Crysvita
burosumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Blenrep
belantamab mafodotin, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Summary of opinion: Ayvakyt
avapritinib, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
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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: 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: 07/04/2020 -
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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: 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 -
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Orphan designation: Eculizumab for: Treatment of neuromyelitis optica spectrum disorders
Date of first decision: 05/08/2013, Positive, Last updated: 20/11/2019 -
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Orphan designation: Eculizumab for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of first decision: 24/07/2009, Positive, Last updated: 20/11/2019 -
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Orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene (onasemnogene abeparvovec) for: Treatment of spinal muscular atrophy
Date of first decision: 19/06/2015, Positive, Last updated: 03/10/2019 -
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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for: Treatment of beta thalassaemia intermedia and major
Date of first decision: 24/01/2013, Positive, Last updated: 03/06/2019 -
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Orphan designation: (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazin-yl)pyrimidin-5-yl)ethan-1-amine (avapritinib) for: Treatment of gastrointestinal stromal tumours
Date of first decision: 17/07/2017, Positive, Last updated: 22/05/2019