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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:
Belgium; Germany; France; United Kingdom; Italy; Netherlands; Czech Republic; Hungary; Poland;

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:
Poxviridae, Vaccinia

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known