Is Ipilimumab 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 Ipilimumab, including YERVOY 5 mg/ml intravenous infusion (5 mg/ml, Intravenous infusion, SAR 14866.60).

Is Ipilimumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ipilimumab, including YERVOY (Prescription).

Is Ipilimumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ipilimumab: Yervoy.

Are there safety signals or safety updates for Ipilimumab?

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

Active substance

Ipilimumab

SFDA 2
US FDA 1
EMA 1
Health Canada 1
Safety 33

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
YERVOY 5 mg/ml intravenous infusion	5 mg/ml	Intravenous infusion · Intravenous use	1 Vial	SAR 14866.60	Biological · Prescription	BRISTOL-MYERS SQUIBB	Valid
YERVOY 5 mg/ml intravenous infusion	5 mg/ml	Intravenous infusion · Intravenous use	1 Vial	SAR 59466.35	Biological · Prescription	BRISTOL-MYERS SQUIBB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

BILIARY TRACT CANCER; COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER; GASTRIC CANCER; HEPATOCELLULAR CARCINOMA; MALIGNANT NEOPLASM OF THE PANCREAS; MELANOMA; MESOTHELIOMA; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); RENAL CELL CARCINOMA (RCC)-CC-RCC & NON-CC RCC; SOFT TISSUE SARCOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
YERVOY	3MG	injectable · injection	BRISTOL MYERS SQUIBB	Prescription	25 Mar 2011

EMA European Union — centrally authorised medicines

Yervoy Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 13 Jul 2011 · ATC L01FX04

Therapeutic indication (EMA)

Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
YERVOY	02379384	5 MG / ML	SOLUTION · INTRAVENOUS	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

US FDA 31 Aug 2026 YERVOY — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; 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 Jun 2023 PRAC signal: Capillary leak syndrome (Opdivo, Yervoy, Keytruda) and cytokine release syndrome (Opdivo)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Feb 2023 PRAC signal: Capillary leak syndrome (Opdivo, Yervoy, Keytruda) and cytokine release syndrome (Opdivo)
Action for MAH: update of the product information: No
EMA PRAC 27 Oct 2022 PRAC signal: Pure red cell aplasia and aplastic anaemia
Action for MAH: update of the product information: No

All safety entries for ipilimumab →

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.