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Notification report

Full notification file


General information

Notification Number
B/NL/14/007

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
10/12/2014

Title of the Project
An open-label, uncontrolled, single-dose, dose-escalation, multi-centre trial investigating the safety and efficacy of systemic administration of AAV5-hFIX, an adeno-associated viral vector containing a codon-optimised human factor IX gene, to severe haemophilia B

Proposed period of release:
01/07/2014 to 31/12/2015

Name of the Institute(s) or Company(ies)
uniQure Biopharma B.V., Meibergdreef 61
1105 BA Amsterdam
The Netherlands;


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

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
The complete name of the vector is: Recombinant adeno-associated viral vector containing the codon-optimized human coagulation factor IX cDNA

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
AAV	Dependovirus	Parvoviridae	Adeno-associated Virus	N/A	Serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known