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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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