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Notification report


Full notification file


General information

Notification Number
B/ES/19/24

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/11/2019

Title of the Project
Phase II, outcomes, assessor-masked multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related to macular degeneration

Proposed period of release:
01/03/2020 to 31/07/2021

Name of the Institute(s) or Company(ies)
Gyroscope Therapeutics Limited, ;


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

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

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


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependoparvovirusAdeno-associated Virus--Serotype 2

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known