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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2680

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
01/03/2016

Title of the Project
Clinical Study JX594-HEP024, “A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy”.

Proposed period of release:
01/10/2016 to 30/06/2020

Name of the Institute(s) or Company(ies)
SillaJen Inc., 450 Sansome St, Suite 650
San Francisco,
CA 94111
USA;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Finland; France; United Kingdom; Italy; Portugal; 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:
Genus: Orthopoxvirus
Species: Vaccinia virus (VV)


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
N/AOrthopoxvirusesvacciniaN/AWyethN/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
29/09/2016 00:00:00
Remarks: