18 results
Keyword luxturna Remove keyword
-
List item
Human medicine European public assessment report (EPAR): Luxturna (updated)
voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa
Date of authorisation: 22/11/2018,
, 
, 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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018Luxturna … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
List of medicines under additional monitoring
Last updated: 16/12/2020 -
List item
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 -
List item
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 -
List item
Download medicine data
Last updated: 29/04/2020 -
List item
Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 14/09/2020 -
List item
CHMP: Agendas, minutes and highlights (updated)
Last updated: 07/01/2021 -
List item
PRAC: Agendas, minutes and highlights (updated)
Last updated: 15/01/2021 -
List item
CAT: Agendas, minutes and reports
Last updated: 24/07/2020 -
List item
Newsletters
Last updated: 10/12/2020 -
List item
Public data from Article 57 database (updated)
Last updated: 21/01/2021