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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2505

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
10/08/2015

Title of the Project
A Randomized, Double-Masked, Sham-Controlled, Pivotal Clinical Trial to Evaluate the Efficacy of a Single Intravitreal Injection of GS010 (rAAV2/2-ND4) in Subjects Affected for more than 6 months and to12 months by Leber Hereditary Optic Neuropathy Due to the G11778A Mutation in the Mitochondrial NADH Dehydrogenase 4 Gene

Proposed period of release:
01/01/2016 to 31/12/2017

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:
Germany; France; United Kingdom; Italy;

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‚ÄźAssociated Virus-serotype 2-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/01/2016 00:00:00
Remarks: