Is Ramucirumab 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 Ramucirumab, including CYRAMZA 10 mg/ml Injection (10 mg/ml, Injection, SAR 11346.00).

Is Ramucirumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ramucirumab, including CYRAMZA (Prescription).

Is Ramucirumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ramucirumab: Cyramza.

Are there safety signals or safety updates for Ramucirumab?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2025-04-07).

Active substance

Ramucirumab

SFDA 2
US FDA 1
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CYRAMZA 10 mg/ml Injection	10 mg/ml	Injection · Intravenous use	1 Vial	SAR 11346.00	Biological · Prescription	Eli Lilly and Company	Valid
CYRAMZA 10 mg/ml Injection	10 mg/ml	Injection · Intravenous use	1 Vial	SAR 2402.60	Biological · Prescription	Eli Lilly and Company	Valid

Indications — CHI Daman Drug Formulary

COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER; GASTRIC CANCER; HEPATOCELLULAR CARCINOMA; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); PLEURAL MESOTHELIOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
CYRAMZA	100MG/10ML; 500MG/50ML	injectable · injection	ELI LILLY AND CO	Prescription	21 Apr 2014

EMA European Union — centrally authorised medicines

Cyramza Eli Lilly Nederland B.V. · Authorised · authorised 19 Dec 2014 · ATC L01FX06

Therapeutic indication (EMA)

Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate. Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5?fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ? 400 ng/ml and who have been previously treated with sorafenib.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CYRAMZA	02443805	10 MG / ML	SOLUTION · INTRAVENOUS	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 7 Apr 2025 CYRAMZA — 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 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Artery dissections and aneurysms
Action for MAH: update of the product information: No

All safety entries for ramucirumab →

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.