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Notification report


Full notification file


General information

Notification Number
B/NL/17/004

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
23/08/2017

Title of the Project
A Phase I/II Open Label Clinical Trial Assessing Safety and Efficacy of Intravesical Instillation of the Recombinant BCG VPM1002BC in Patients with Recurrent Non-Muscle Invasive Bladder Cancer after Standard BCG Therapy

Proposed period of release:
30/11/2017 to 31/03/2022

Name of the Institute(s) or Company(ies)
Swiss Group for Clinical Cancer Research (SAKK), Effingerstr. 33, 3008 Bern, Switzerland;


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

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

If yes, notification number(s):


GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Bacteria; Actinobacteria; Actinomycetales; Corynebacterineae; Mycobacteriaceae; Mycobacterium; M. bovis; Strain BCG subtype Prague (recombinant Bacille Calmette Guérin (rBCG)).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
BCGMycobacteriumbovis-BCG subtype Prague-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known