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Notification report

Full notification file


General information

Notification Number
B/NL/10/003

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
04/03/2010

Title of the Project
Intradermal vaccination with naked DNA encoding the fusion protein domain1 of tetanus toxin fragment C and MART-1(aa 26-35) for the induction of MART-1-specific T cell immunity in stage IV melanoma patients

Proposed period of release:
01/07/2010 to 01/07/2020

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
Other: False

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 Name	Genus	Species	Subspecies	Strain	Pathovar
-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known