Is Tremelimumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Tremelimumab, including Imjudo (20 mg/ml, Concentrate for solution for infusion, SAR 80366.80); Imjudo (25 mg/ml, Concentrate for solution for infusion, SAR 6697.25).

Is Tremelimumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Tremelimumab, including IMJUDO (Prescription); IMJUDO (Prescription).

Is Tremelimumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tremelimumab: Imjudo.

Are there safety signals or safety updates for Tremelimumab?

EMA PRAC: 11 entries; US FDA: 1 entry (latest 2026-08-31).

Active substance

Tremelimumab

SFDA 2
US FDA 2
EMA 2
Health Canada 1
Safety 12

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Imjudo	20 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 80366.80	Biological · Prescription	AstraZeneca AB	Valid
Imjudo	25 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 6697.25	Biological · Prescription	AstraZeneca	Valid

Indications — CHI Daman Drug Formulary

ESOPHAGEAL CANCER; HEPATOCELLULAR CARCINOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
IMJUDO	25MG/1.25ML(20MG/ML); 300MG/15ML(20MG/ML)	injectable · intravenous	ASTRAZENECA AB	Prescription	21 Oct 2022
IMJUDO	25MG/1.25ML(20MG/ML); 300MG/15ML(20MG/ML)	injectable · intravenous	ASTRAZENECA AB	Prescription	10 Nov 2022

EMA European Union — centrally authorised medicines

Imjudo AstraZeneca AB · Authorised · authorised 20 Feb 2023 · ATC L01FX20

Therapeutic indication (EMA)

Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Tremelimumab AstraZeneca AstraZeneca AB · Withdrawn · authorised 20 Feb 2023 · ATC L01FX20

Therapeutic indication (EMA)

Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMJUDO	02541009	20 MG / ML	SOLUTION · INTRAVENOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 31 Aug 2026 IMJUDO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jun 2026 PRAC signal: Acquired haemophilia
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2025 PRAC signal: Scleroderma, systemic scleroderma, morphea
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2025 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2024 PRAC signal: Scleroderma, systemic scleroderma, morphea
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2024 PRAC signal: Thrombotic microangiopathy
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2024 PRAC signal: Coeliac disease
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2024 PRAC signal: Pancreatic failure
Action for MAH: update of the product information: Yes
EMA PRAC 8 Feb 2024 PRAC signal: Coeliac disease
Action for MAH: update of the product information: No
EMA PRAC 8 Feb 2024 PRAC signal: Pancreatic failure
Action for MAH: update of the product information: No
EMA PRAC 31 Aug 2023 PRAC signal: Coeliac disease
Action for MAH: update of the product information: No
EMA PRAC 31 Aug 2023 PRAC signal: Pancreatic failure
Action for MAH: update of the product information: No

All safety entries for tremelimumab →

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.