Is Gadofosveset trisodium approved by the US FDA?

Drugs@FDA lists 1 application product line for Gadofosveset trisodium, including ABLAVAR (Discontinued).

Is Gadofosveset trisodium authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Gadofosveset trisodium.

Active substance

Gadofosveset trisodium

US FDA 1
EMA 1

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

Product	Strength	Form · route	Applicant	Status	First approved
ABLAVAR	2440MG/10ML (244MG/ML); 3660MG/15ML (244MG/ML)	solution · intravenous	LANTHEUS MEDCL	Discontinued	22 Dec 2008

EMA European Union — centrally authorised medicines

Ablavar (previously Vasovist) TMC Pharma Services Ltd. · Withdrawn · authorised 3 Oct 2005 · ATC V08CA

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only. Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.

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.