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Notification report


Full notification file


General information

Notification Number
B/ES/15/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
27/03/2015

Title of the Project
A Phase 3b, Multicentre, Single-arm, expanded Access Protocol of Talimogene Laherparepvec for the treatment of Subjects in Europe with Unresected Stage IIIB to IVM1c Melanoma. (20120328)

Proposed period of release:
01/02/2015 to 31/07/2017

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:
Austria; Germany; France; United Kingdom; Italy; Netherlands; Sweden;

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: 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 1JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
12/05/2015 00:00:00
Remarks: