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Notification report


Full notification file


General information

Notification Number
B/ES/18/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/06/2018

Title of the Project
Efficacy and Safety of Bilateral Intravitreal Injection of GS010: A Randomized, Double-Masked, Placebo-Controlled Trial in Subjects Affected with G11778A ND4 Leber Hereditary Optic Neuropathy for Up to One Year.

Proposed period of release:
01/01/2018 to 30/03/2021

Name of the Institute(s) or Company(ies)
GENSIGHT Biologics, 74 rue du Faubourg Saint-Antoine
75012 Paris
France;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; France; United Kingdom; Italy; Netherlands;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Parvoviridae
Genus: Dependovirus
Species: AAV-derived replication-deficient vector


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependovirusAdeno-associated Virus-serotype 2-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known