Is Dostarlimab 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 Dostarlimab, including Jemperli (50 mg/ml, Concentrate for solution for infusion, SAR 27974.20).

Is Dostarlimab approved by the US FDA?

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

Is Dostarlimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dostarlimab: Jemperli.

Are there safety signals or safety updates for Dostarlimab?

EMA PRAC: 11 entries; US FDA: 1 entry (latest 2026-06-11).

Active substance

Dostarlimab

SFDA 1
US FDA 2
EMA 1
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
Jemperli	50 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 27974.20	Biological · Prescription	GLAXO SAUDI ARABIA	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; ENDOMETRIAL CANCER; ESOPHAGEAL CANCER; GASTRIC CANCER; HEPATOCELLULAR CARCINOMA; MALIGNANT NEOPLASM OF THE PANCREAS

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

Product	Strength	Form · route	Applicant	Status	First approved
JEMPERLI	500MG/10ML	injectable · injection	GLAXOSMITHKLINE	Prescription	22 Apr 2021
JEMPERLI	500MG/10ML	injectable · injection	GLAXOSMITHKLINE LLC	Prescription	17 Aug 2021

EMA European Union — centrally authorised medicines

Jemperli GlaxoSmithKline Trading Services Limited · Authorised · authorised 21 Apr 2021 · ATC L01FF07

Therapeutic indication (EMA)

Jemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability‑high (MSI‑H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum‑containing regimen.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JEMPERLI	02523434	50 MG / ML	SOLUTION · INTRAVENOUS	GLAXOSMITHKLINE INC

Safety signals and safety-related labeling changes

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
US FDA 1 Aug 2024 JEMPERLI — 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 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 dostarlimab →

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.