Is Gadobutrol 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 Gadobutrol, including GADOVIST 1MMOL-ML PRE-FILLED SYRINGE (1 mmol/ml, Solution for injection, SAR 1085.25).

Is Gadobutrol approved by the US FDA?

Drugs@FDA lists 8 application product lines for Gadobutrol, including GADAVIST (Prescription); GADOBUTROL (Prescription); GADOBUTROL (Prescription); GADOBUTROL (Prescription); GADOBUTROL (Prescription).

Are there safety signals or safety updates for Gadobutrol?

US FDA: 1 entry (latest 2026-02-13).

Active substance

Gadobutrol

SFDA 2
US FDA 8
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GADOVIST 1MMOL-ML PRE-FILLED SYRINGE	1 mmol/ml	Solution for injection · Intravenous use	5 Pre-filled syringe	SAR 1085.25	NCE · Prescription	BAYER PHARMA AG	Valid
GADOVIST 1MMOL-ML PRE-FILLED SYRINGE	1 mmol/ml	Solution for injection · Intravenous use	1 Vial	SAR 386.10	NCE · Prescription	BAYER AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
GADAVIST	4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML); 18.1416GM/30ML (604.72MG/ML); 39.3068GM/65ML (604.72MG/ML); 1.20944GM/2ML (604.72MG/ML)	solution · intravenous	BAYER HLTHCARE	Prescription	14 Mar 2011
GADOBUTROL	1.20944GM/2ML (604.72MG/ML); 4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML)	solution · intravenous	HENGRUI PHARMA	Prescription	17 Nov 2022
GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML); 1.20944GM/2ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 18.1416GM/30ML (604.72MG/ML); 39.3068GM/65ML (604.72MG/ML)	solution · intravenous	HAINAN POLY PHARM	Prescription	15 Mar 2023
GADOBUTROL	18.1416GM/30ML (604.72MG/ML); 39.3068GM/65ML (604.72MG/ML)	solution · intravenous	HENGRUI PHARMA	Prescription	8 Sep 2023
GADOBUTROL	1.20944GM/2ML (604.72MG/ML); 4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML); 18.1416GM/30ML (604.72MG/ML); 39.3068GM/65ML (604.72MG/ML)	solution · intravenous	ZENARA	Prescription	8 Jun 2026
GADOBUTROL	4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML)	solution · intravenous	VIWIT PHARM	Prescription	11 Jun 2026
PIXXOSCAN	1.20944GM/2ML (604.72MG/ML); 4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML)	solution · intravenous	GE HLTHCARE	Prescription	29 Jun 2026
GADOBUTROL	1.20944GM/2ML (604.72MG/ML); 4.5354GM/7.5ML (604.72MG/ML); 6.0472GM/10ML (604.72MG/ML); 9.0708GM/15ML (604.72MG/ML)	solution · intravenous	HENGRUI PHARMA	Discontinued	8 Sep 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
GADOVIST 1.0	02241089	604.72 MG / ML	SOLUTION · INTRAVENOUS	BAYER INC
PIXXOSCAN	02553678	604.72 MG / ML	SOLUTION · INTRAVENOUS	GE HEALTHCARE CANADA INC

Safety signals and safety-related labeling changes

US FDA 13 Feb 2026 GADAVIST — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for gadobutrol →

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.