Active substance
Gadopentetate dimeglumine
- SFDA 1
- US FDA 2
- Health Canada 1
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MAGNEVIST INJ. | 469.01 mg | Solution for injection · Intravenous use | 10 Ampoule | SAR 1735.25 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MAGNEVIST | 01989987 | 469 MG / ML | SOLUTION · INTRAVENOUS | BAYER INC |
Safety signals and safety-related labeling changes
- US FDA 25 Jul 2018 MAGNEVIST — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Jul 2018 MAGNEVIST — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.