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Notification report

Full notification file


General information

Notification Number
B/ES/08/46

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
05/07/2008

Title of the Project
A Multicenter, Double Blind, Placebo controlled, Randomized study of TroVax® vs.
Placebo in the First Line treatment of Patients with Metastatic Colorectal Cancer receiving
chemo-based therapy – EFC10528.

Proposed period of release:
01/10/2008 to 30/09/2012

Name of the Institute(s) or Company(ies)
Sanofi-Aventis Recherche et Développement, 1, Avenue Pierre Brossolette
91385 Chilly-Mazarin
France;


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


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

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Poxviridae, Vaccinia

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	Orthopoxvirus

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known