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Notification report


Full notification file


General information

Notification Number
B/ES/15/07

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
21/07/2015

Title of the Project
A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected into Liver Tumors (20140318)

Proposed period of release:
12/10/2015 to 29/09/2017

Name of the Institute(s) or Company(ies)
Amgen Limited, UK, On behalf of Amgen Inc. (study sponsor);


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


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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Genus:
Simplexvirus

Species:
Talimogene laherparepvec is a recombinant of a wild-type Herpes simplex virus 1 (HSV-1) strain JS1, with genes ICP34.5 and ICP47 deleted and hGM-CSF inserted


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HSV-1SimplexvirusHerpes simplex virus 1-JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
14/12/2015 00:00:00
Remarks: