Is Axicabtagene ciloleucel 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 Axicabtagene ciloleucel, including Yescarta (2000000 cells, Suspension for injection, SAR 1638037.50).

Is Axicabtagene ciloleucel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Axicabtagene ciloleucel: Yescarta.

Are there safety signals or safety updates for Axicabtagene ciloleucel?

EMA PRAC: 9 entries (latest 2026-04-10).

Active substance

Axicabtagene ciloleucel

SFDA 1
EMA 1
Health Canada 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Yescarta	2000000 cells	Suspension for injection · Intravenous use	1 Bag	SAR 1638037.50	Biological · Prescription	Gilead Sciences Ireland UC	Valid

Indications — CHI Daman Drug Formulary

DIFFUSE LARGE B CELL LYMPHOMA; FOLLICULAR LYMPHOMA; MEDIASTINAL LARGE B CELL LYMPHOMA

EMA European Union — centrally authorised medicines

Yescarta Kite Pharma EU B.V. · Authorised · authorised 23 Aug 2018 · ATC L01XX70

Therapeutic indication (EMA)

Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
YESCARTA	02485648	200000000 CELLS / BAG	SUSPENSION · INTRAVENOUS	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 10 Apr 2026 PRAC signal: Increased risk of brain oedema in primary mediastinal large B-cell lymphoma (PMBCL) patients
Action for MAH: update of the product information: Yes
EMA PRAC 27 Nov 2025 PRAC signal: Increased risk of brain oedema in primary mediastinal large B-cell lymphoma (PMBCL) patients
Action for MAH: update of the product information: No
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 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
EMA PRAC 30 Nov 2023 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 6 Jul 2023 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No

All safety entries for axicabtagene ciloleucel →

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.