Is Tisagenlecleucel registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Tisagenlecleucel, including Kymriah (6 cells, Dispersion for infusion, SAR 1633500.00).

Is Tisagenlecleucel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tisagenlecleucel: Kymriah.

Are there safety signals or safety updates for Tisagenlecleucel?

EMA PRAC: 7 entries (latest 2025-07-10).

Active substance

Tisagenlecleucel

SFDA 1
EMA 1
Health Canada 1
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Kymriah	6 cells	Dispersion for infusion · Intravenous use	1 Bag	SAR 1633500.00	Biological · Prescription	Novartis Europharm Limited	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)

EMA European Union — centrally authorised medicines

Kymriah Novartis Europharm Limited · Authorised · authorised 23 Aug 2018 · ATC L01XL04

Therapeutic indication (EMA)

Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post transplant or in second or later relapse. • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
KYMRIAH	02480514	600000000 CELLS	SUSPENSION · INTRAVENOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 10 Jul 2025 PRAC signal: Progressive multifocal leukoencephalopathy
Action for MAH: update of the product information: Yes
EMA PRAC 5 Jun 2025 PRAC signal: Immune-mediated enterocolitis / immune effector cell-associated enteritis with CAR T-cell products
Action for MAH: update of the product information: Yes
EMA PRAC 13 Feb 2025 PRAC signal: Progressive multifocal leukoencephalopathy
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2025 PRAC signal: Immune-mediated enterocolitis
Action for MAH: update of the product information: No
EMA PRAC 13 Jun 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: No

All safety entries for tisagenlecleucel →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.