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Notification report


Full notification file


General information

Notification Number
B/NL/15/002

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
01/06/2015

Title of the Project
The AGM0001Study: A phase 3 double-blind, randomized, placebo- controlled study to evaluate the safety and efficacy of AGM0001 in subjects with critical limb ischemia.

Proposed period of release:
01/08/2015 to 01/08/2020

Name of the Institute(s) or Company(ies)
University Medical Center Utrecht, Utrecht, the Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
Other: Purified plasmid DNA (pDNA) drug substance.

Identity of the GMO:
Not relevant. The plasmid DNA does not have a taxonomic classification.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
pVAX1-----

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known