Is Ciltacabtagene autoleucel 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 Ciltacabtagene autoleucel, including CARVYKTI (100000000 cells, Intravenous infusion, SAR 2409034.95).

Is Ciltacabtagene autoleucel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ciltacabtagene autoleucel: Carvykti.

Are there safety signals or safety updates for Ciltacabtagene autoleucel?

EMA PRAC: 2 entries (latest 2025-07-10).

Active substance

Ciltacabtagene autoleucel

SFDA 1
EMA 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CARVYKTI	100000000 cells	Intravenous infusion · Intravenous use	1 Bag	SAR 2409034.95	Biological · Prescription	JANSSEN PHARMACEUTICA N.V	Valid

EMA European Union — centrally authorised medicines

Carvykti Janssen-Cilag International NV · Authorised · authorised 25 May 2022 · ATC L01XL05

Therapeutic indication (EMA)

Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.

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 13 Feb 2025 PRAC signal: Progressive multifocal leukoencephalopathy
Action for MAH: update of the product information: No

All safety entries for ciltacabtagene autoleucel →

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.