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Notification report

Full notification file


General information

Notification Number
B/FR/13/GT02

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
25/04/2013

Title of the Project
A phase I/II, open‐label, study of intracerebral administration of adeno‐associated viral vector containing the human alpha‐N‐acetylglucosaminidase gene for the treatment of Sanfilippo type B syndrome

Proposed period of release:
01/04/2013 to 30/09/2013

Name of the Institute(s) or Company(ies)
Institut Pasteur, ;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
AAV2.5‐hNaGlu is an Adeno‐Associated Virus serotypes 2 and 5 carrying the human alpha‐N‐acetylglucosaminidase gene.
Genus: Dependovirus
Family: Parvoviridae

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Adeno-associated virus	Dependovirus	Adeno‐Associated Virus	Parvoviridae/Parvoviriae	N/A	N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known