Back

Notification report

Full notification file


General information

Notification Number
B/NL/08/004

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
05/05/2009

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:
15/07/2009 to 01/07/2011

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;


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

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

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 Name	Genus	Species	Subspecies	Strain	Pathovar
Lactococcus lactis	Lactococcus	L. lactis	cremoris	MG1363

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known