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Notification report


Full notification file


General information

Notification Number
B/ES/16/01

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/12/2015

Title of the Project
A Phase 1, Multi-center, Open-label, Dose
De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous SystemTumors That are Amenable to Direct Injection


Proposed period of release:
01/01/2016 to 30/11/2018

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:
Belgium; Germany; Spain; France; Greece; Netherlands; Portugal; Sweden;

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

If yes, notification number(s):
B/ES/14/05; B/ES/14/06; B/ES/14/08; B/ES/15/04; B/FR/15/GT01; B/FR/15/GT06; B/FR/15/GT07; B/HU/14/01; B/SE/14/EU-2014-000185-22;

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-1SimplexvirusHSV-1-JS1 (ECACC Accession Number 01010209)-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
03/04/2016 00:00:00
Remarks: