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Notification report


Full notification file


General information

Notification Number
B/SE/08/EU-2008-000967-40

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
02/06/2008

Title of the Project
A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multicenter Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis

Proposed period of release:
22/08/2008 to 01/07/2011

Name of the Institute(s) or Company(ies)
ActoGeniX N.V., ;


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

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

If yes, notification number(s):
B/BE/07/BVW1;

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Lactococcus lactis subsp. cremoris

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Lactococcus lactisLactococcusL. lactiscremorisMG1363

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known