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Notification report

Full notification file


General information

Notification Number
B/ES/18/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
06/07/2018

Title of the Project
A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Proposed period of release:
31/08/2018 to 17/11/2026

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:
Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Italy; Luxembourg; Netherlands; Portugal; Sweden; Cyprus; Czech Republic; Estonia; Hungary; Lithuania; Latvia; Malta; Poland; Slovenia; Slovak Republic; Iceland; Liechtenstein; Norway; Bulgaria; Romania; Croatia;

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

If yes, notification number(s):
B/DE/15/PEI/2484; B/ES/15/08; B/ES/17/04; B/NL/15/012;

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Autologous T cells transduced with a replication-deficient HIV-1 derived viral vector to express a chimeric (murine/human) antigen receptor (CAR).

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
human	Homo	Sapiens	-	-	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/12/2018 00:00:00
Remarks: