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Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018,
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, Revision: 2, Authorised, Last updated: 30/01/2020
Luxturna Leber Congenital Amaurosis Retinitis … Luxturna … Luxturna voretigene neparvovec voretigene … -
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Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for: Treatment of retinitis pigmentosa
Date of first decision: 28/07/2015, Positive, Last updated: 04/03/2019been authorised in the EU as Luxturna since 22 November 2018. The … Luxturna Luxturna voretigene neparvovec Adenovirus-associated … the orphan designation of Luxturna at the time of marketing … -
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Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec) for: Treatment of Leber's congenital amaurosis
Date of first decision: 02/04/2012, Positive, Last updated: 04/03/2019been authorised in the EU as Luxturna since 22 November 2018. The … Luxturna Luxturna voretigene neparvovec Adenovirus-associated … the orphan designation of Luxturna at the time of marketing … -
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Press release: New gene therapy for rare inherited disorder causing vision loss recommended for approval
Last updated: 21/09/2018recommended for approval Luxturna is the first treatment option … authorisation for the gene therapy Luxturna (voretigene neparvovec … as aids for low vision. Luxturna is meant for patients with … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018Luxturna … -
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Orphan designation: Adeno-associated virus serotype 8 containing the human RdCVF sequence and the human RdCVFL sequence for: Treatment of inherited retinal dystrophies
Date of first decision: 28/02/2020, Positive, Last updated: 05/05/2020medicines Raxone (idebenone) and Luxturna (voretigene neparvovec) were … -
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Orphan designation: Combination of three adeno-associated viral vectors of serotype 8 containing the 5'-, the body- and the 3'- coding sequences of human CEP290 fused to inteins for: Treatment of inherited retinal dystrophies
Date of first decision: 28/02/2020, Positive, Last updated: 06/05/2020designation, the medicine Luxturna was authorised in the EU … -
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Committee for Advanced Therapies (CAT): 23-25 May 2018
European Medicines Agency, London, UK, from 23/05/2018 to 25/05/2018, Last updated: 25/05/2018 -
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CAT: Agendas, minutes and reports (updated)
Last updated: 24/07/2020 -
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Newsletters (updated)
Last updated: 17/07/2020