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Notification report


Full notification file


General information

Notification Number
B/NL/18/008

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
07/06/2018

Title of the Project
Open‐label, single‐dose, multi‐centre trial investigating an adeno‐associated viral vector containing a codon‐optimized Padua derivative of human factor IX gene (AAV5‐hFIXco‐ Padua, AMT‐061) administered to adult patients with severe or moderately‐severe hemophilia B.

Proposed period of release:
01/10/2018 to 31/12/2030

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:
Belgium; Denmark; Spain; France; United Kingdom; Ireland; Italy; Czech Republic;

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


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAVDependovirusParvoviridaeAdeno-associated Virus-Serotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known