Is Avelumab 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 Avelumab, including BAVENCIO (20 mg/ml, Solution for infusion, SAR 4121.10).

Is Avelumab approved by the US FDA?

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

Is Avelumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Avelumab: Bavencio.

Are there safety signals or safety updates for Avelumab?

EMA PRAC: 20 entries; US FDA: 1 entry (latest 2026-08-31).

Active substance

Avelumab

SFDA 1
US FDA 2
EMA 1
Health Canada 1
Safety 21

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BAVENCIO	20 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 4121.10	Biological · Prescription	Merck Europe BV	Valid

Indications — CHI Daman Drug Formulary

BLADDER CANCER; DIFFUSE LARGE B CELL LYMPHOMA; EXTRA-NODAL T CELL LYMPHOMA; FOLLICULAR LYMPHOMA; RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC

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

Product	Strength	Form · route	Applicant	Status	First approved
BAVENCIO	20MG/ML	injectable · injection	EMD SERONO INC	Prescription	23 Mar 2017
BAVENCIO	20MG/ML	injectable · intravenous	EMD SERONO INC	Prescription	9 May 2017

EMA European Union — centrally authorised medicines

Bavencio Merck Europe B.V. · Authorised · authorised 18 Sep 2017 · ATC L01FF04

Therapeutic indication (EMA)

Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Bavencio is indicated as monotherapy for the first?line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum?based chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BAVENCIO	02469723	20 MG / ML	SOLUTION · INTRAVENOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA

Safety signals and safety-related labeling changes

US FDA 31 Aug 2026 BAVENCIO — 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 8 Jul 2021 PRAC signal: Immune-mediated cystitis
Action for MAH: update of the product information: Yes
EMA PRAC 6 May 2021 PRAC signal: Immune-mediated cystitis
Action for MAH: update of the product information: No
EMA PRAC 29 Oct 2020 PRAC signal: Eosinophilic fasciitis
Action for MAH: update of the product information: No

All safety entries for avelumab →

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.