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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: 3, Authorised, Last updated: 05/01/2021
Luxturna Leber Congenital Amaurosis Retinitis … voretigene neparvovec Overview Luxturna is a medicine that is used … at the back of the eye). Luxturna can only be used while patients … -
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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 … the orphan designation of Luxturna at the time of marketing … Luxturna Luxturna voretigene neparvovec Adenovirus-associated … -
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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 … the orphan designation of Luxturna at the time of marketing … Luxturna Luxturna voretigene neparvovec Adenovirus-associated … -
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Press release: New gene therapy for rare inherited disorder causing vision loss recommended for approval
Last updated: 21/09/2018Press release 21/09/2018 Luxturna is the first treatment option … authorisation for the gene therapy Luxturna (voretigene neparvovec … such 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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Orphan designation: Adeno-associated virus serotype 2/8 vector containing the human PDE6A gene for: Treatment of retinitis pigmentosa
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020PDE6A gene. The medicine Luxturna was authorised in the EU … -
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European Medicines Agency (EMA) Patients' and Consumers'(PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting (updated)
Virtual meeting, from 02/03/2021 to 03/03/2021, Last updated: 31/05/2021 -
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Committee for Orphan Medicinal Products (COMP): 13-15 April 2021 (updated)
European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021, Last updated: 11/06/2021 -
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List of medicines under additional monitoring (updated)
Last updated: 26/05/2021 -
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Committee for Orphan Medicinal Products (COMP): 19-21 January 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/01/2021 to 21/01/2021, Last updated: 03/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 31 August-3 September 2020
Virtual meeting, from 31/08/2020 to 03/09/2020, Last updated: 27/02/2018 -
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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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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 March 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/03/2021 to 11/03/2021, Last updated: 27/02/2018 -
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Download medicine data
Last updated: 29/04/2020 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 07/06/2021 -
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CAT: Agendas, minutes and reports
Last updated: 05/02/2021 -
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COMP: Agendas, minutes and meeting reports
Last updated: 03/02/2021 -
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Public data from Article 57 database (updated)
Last updated: 02/06/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 March 2021
PRAC, Last updated: 12/03/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021