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Notification report


Full notification file


General information

Notification Number
B/NL/17/001

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
23/02/2017

Title of the Project
Evaluation of safety and efficacy of an intravenous injection of GNT0003, a suspension of recombinant AAV8 viral vector carrying the human UGT1A1 transgene, in patients with Crigler-Najjar syndrome.

Proposed period of release:
01/07/2017 to 01/12/2030

Name of the Institute(s) or Company(ies)
University of Amsterdam, Academic Medical Center of the University of Amsterdam;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
France; Italy;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Order: Parvoviridae
Genus: Dependoparvovirus
Species: Adeno-associated virus (AAV)
Strain: the GMO is a pseudotyped AAV vector
ITRs present in the vector genome are derived from AAV serotype 2
The capsid consists of a capsid of AAV serotype 8
Common name: AAV2/8 or AAV8


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2DependovirusAdeno‐Associated Virus---
AAV8DependovirusAdeno‐Associated Virus---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known