Is Durvalumab 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 Durvalumab, including IMFINZI 120 mg / 2.4 ml (50 mg/ml, Solution for infusion, SAR 2787.50); IMFINZI 500 mg / 10 ml (50 mg/ml, Solution for infusion, SAR 11614.50).

Is Durvalumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Durvalumab, including IMFINZI (Prescription).

Is Durvalumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Durvalumab: Imfinzi.

Are there safety signals or safety updates for Durvalumab?

EMA PRAC: 26 entries; US FDA: 1 entry (latest 2026-08-31).

Active substance

Durvalumab

SFDA 2
US FDA 1
EMA 1
Health Canada 1
Safety 27

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
IMFINZI 120 mg / 2.4 ml	50 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 2787.50	Biological · Prescription	AstraZeneca UK Limited	Valid
IMFINZI 500 mg / 10 ml	50 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 11614.50	Biological · Prescription	AstraZeneca UK Limited	Valid

Indications — CHI Daman Drug Formulary

BILIARY TRACT CANCER; Cervical Cancer; ENDOMETRIAL CANCER; ESOPHAGEAL CANCER; GASTRIC CANCER; HEPATOCELLULAR CARCINOMA; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); SMALL CELL LUNG CANCER (SCLC)

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

Product	Strength	Form · route	Applicant	Status	First approved
IMFINZI	50MG/ML	injectable · injection	ASTRAZENECA UK LTD	Prescription	1 May 2017

EMA European Union — centrally authorised medicines

Imfinzi AstraZeneca AB · Authorised · authorised 21 Sep 2018 · ATC L01XC28

Therapeutic indication (EMA)

Non-Small Cell Lung Cancer (NSCLC)Imfinzi in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements (for selection criteria, see section 5.1). Imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations. Small Cell Lung Cancer (SCLC)Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). Biliary Tract Cancer (BTC)Imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (BTC). Hepatocellular Carcinoma (HCC)Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Endometrial Cancer Imfinzi in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with: - Imfinzi as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) - Imfinzi in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR). Muscle Invasive Bladder Cancer (MIBC) Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC). Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC) Imfinzi in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant Imfinzi monotherapy, is indicated for the treatment of adults with resectable gastric or gastro‑oesophageal junction adenocarcinoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMFINZI	02468816	50 MG / ML	SOLUTION · INTRAVENOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 31 Aug 2026 IMFINZI — 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
EMA PRAC 27 Oct 2022 PRAC signal: Myelitis transverse
Action for MAH: update of the product information: Yes
EMA PRAC 10 Jun 2022 PRAC signal: Myelitis transverse
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2022 PRAC signal: Arthralgia
Action for MAH: update of the product information: Yes

All safety entries for durvalumab →

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.