Active substance
Brexucabtagene autoleucel
- SFDA 2
- Health Canada 2
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Tecartus | 1 * 10^6 + 1 * 10^8 cells | Cell suspension for infusion · Intravenous use | 1 Bag | SAR 1694937.75 | Biological · Prescription | Gilead Sciences Ireland UC | Valid |
| Tecartus | 2 * 10^6 + 2 * 10^8 cells | Cell suspension for infusion · Intravenous use | 1 Bag | SAR 1694937.75 | Biological · Prescription | Gilead Sciences Ireland UC | Valid |
Indications — CHI Daman Drug Formulary
MANTLE CELL LYMPHOMA
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- 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
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.