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Orphan designation: fidanacogene elaparvovec for: Treatment of haemophilia B
Date of designation: 19/11/2018, Positive, Last updated: 19/02/2019 -
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Orphan designation: Rozanolixizumab for: Treatment of myasthenia gravis
Date of designation: 22/04/2020, Positive, Last updated: 13/08/2020 -
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Orphan designation: Autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B-cell maturation antigen-specific chimeric antigen receptor for: Treatment of multiple myeloma
Date of designation: 09/12/2020, Withdrawn, Last updated: 26/05/2021