Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
Phase III, open-label, single-dose, multi-centre multinational trial investigating a serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene (AAV5-hFIXco-Padua, AMT-061) administered to adult subjects with severe or moderately-severe hemophilia B

Proposed period of release:
01/01/2019 to 31/12/2021

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?
Belgium; Denmark; Spain; Finland; France; United Kingdom; Italy; Sweden;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
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 VirusN/ASerotype 5

European Commission administrative information

Consent given by the Member State Competent Authority:
05/03/2019 00:00:00