Ablavar (previously Vasovist)

RSS

gadofosveset trisodium

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/11/2011

Authorisation details

Product details
Name
Ablavar (previously Vasovist)
Agency product number
EMEA/H/C/000601
Active substance
gadofosveset trisodium
International non-proprietary name (INN) or common name
gadofosveset trisodium
Therapeutic area (MeSH)
Magnetic Resonance Angiography
Anatomical therapeutic chemical (ATC) code
V08CA
Publication details
Marketing-authorisation holder
TMC Pharma Services Ltd.
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
03/10/2005
Contact address
Finchampstead
Berkshire RG40 4LJ
United Kingdom

Product information

15/05/2011 Ablavar (previously Vasovist) - EMEA/H/C/000601 - IB/0020

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Contrast media

Therapeutic indication

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.

Assessment history

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