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Notification report


Full notification file


General information

Notification Number
B/NL/19/024

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
14/01/2020

Title of the Project
A Phase II masked, multicentre, randomised clinical study investigating GT005 (comprising recombinant AAV2 and a native human complement factor transgene) for the treatment of subjects with geographic atrophy secondary to age-related macular degeneration (AMD)

Proposed period of release:
01/01/2020 to 30/09/2021

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


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

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 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:
Yes
16/04/2020 00:00:00
Remarks: