Full notification file
General informationNotification NumberB/ES/18/23Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority20/09/2018Title of the ProjectTisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)Proposed period of release:01/11/2018 to 15/03/2025Name 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?YesIf yes, notification number(s): B/DE/15/PEI/2484; B/ES/15/08; B/ES/17/04; B/ES/18/16; B/ES/18/18; B/ES/18/19; B/NL/15/012; GMO characterizationGMO is a:Other: mammalIdentity 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 derivedCommon Name | Genus | Species | Subspecies | Strain | Pathovar | Human | Homo | Sapiens | - | - | - |
|
European Commission administrative informationConsent given by the Member State Competent Authority:Yes13/12/2018 00:00:00Remarks: