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Notification report


Full notification file


General information

Notification Number
B/DE/15/PEI/2484

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
24/07/2015

Title of the Project
A clinical study to determine the efficacy and safety of CTL019, an investigational gene therapy, in children and adolescent patients with a recurrent form of B-cell acute lymphoblastic leukaemia

Proposed period of release:
01/12/2015 to 31/03/2021

Name of the Institute(s) or Company(ies)
Novartis Pharma AG, Postfach, 4002 Basel, Switzerland;


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


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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: human

Identity of the GMO:


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
21/01/2016 00:00:00
Remarks: