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329 results
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Summary of opinion: Elzonris
tagraxofusp, opinion date: 23/07/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Bluevac BTV (previously known as Bluevac BTV8)
opinion date: 18/06/2020, Positive, Last updated: 19/06/2020 -
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Summary of opinion: Tecartus
opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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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: Onbevzi
bevacizumab, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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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: Qutavina
teriparatide, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
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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: Retsevmo
selpercatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lenalidomide Krka d.d. Novo mesto
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lenalidomide KrKa
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Yuflyma
adalimumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Inrebic
fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lenalidomide Krka d.d.
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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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: COVID-19 Vaccine Moderna
COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 06/01/2021, Positive, Last updated: 06/01/2021 -
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Orphan designation: Fenfluramine hydrochloride for: Treatment of Dravet syndrome (updated)
Date of first decision: 18/12/2013, Positive, Last updated: 08/01/2021 -
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Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA for: treatment of metachromatic leukodystrophy (updated)
Date of first decision: 13/04/2007, Positive, Last updated: 22/12/2020 -
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Orphan designation: Treosulfan for: Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Date of first decision: 22/02/2004, Positive, Last updated: 11/12/2020 -
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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: 10/12/2020 -
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Orphan designation: (S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine (pretomanid) for: Treatment of tuberculosis
Date of first decision: 29/11/2007, Positive, Last updated: 09/12/2020