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Notification report


Full notification file


General information

Notification Number
B/NL/13/002

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
09/01/2013

Title of the Project
Intradermal vaccination with naked DNA, TTFC-E7SH, encoding the fusion protein domain1 of tetanus toxin fragment C and the shuffled version of the Human papilloma virus (HPV) E7 oncoprotein for the induction of E7 specific T cell immunity in stage IV squamous cell cancer patients

Proposed period of release:
09/04/2013 to 09/04/2023

Name of the Institute(s) or Company(ies)
Stichting Het Nederlands Kanker Instituut, Plesmanlaan 121
1066 CX Amsterdam
PO Box 90203
1006 BE Amsterdam;


3. Is the same GMO release planned elsewhere in the Community?
Not known

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

GMO characterization

GMO is a:
Other: no taxonomic classification.

Identity of the GMO:
The medicinal product is not a GMO per se. It is an investigational gene therapy medicinal product consisting of a purified plasmid DNA (pDNA) drug substance.
The plasmid DNA does not have a taxonomic classification.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Plasmid TTFC-E7SH-----

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known