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Notification report


Full notification file


General information

Notification Number
B/IE/18/01

Member State to which the notification was sent
Ireland

Date of acknowledgement from the Member State Competent Authority
28/06/2018

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?
Yes:
Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Italy; Netherlands; Sweden;

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

If yes, notification number(s):


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