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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI3793

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
19/06/2019

Title of the Project
A Phase I/II, Baseline-controlled, Open label, Single Ascending Dose Study of a Novel Adeno-associated Viral Vector (AAV) (FLT190) in Patients With Fabry Disease (MARVEL1).

Proposed period of release:
01/01/2020 to 30/06/2020

Name of the Institute(s) or Company(ies)
Freeline Therapeutics Limited, Stevenage Bioscience Catalyst
Gunnels Wood Road
Stevenage
SG1 2FX
UK;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany; Denmark; United Kingdom; Italy; Norway;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Family: Parvoviridae,
Genus: Dependovirus,
Species: Adeno-associated virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Adeno associated virusDependovirusAdeno-associated dependoparvovirus--AAV2

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/02/2020 00:00:00
Remarks: