Ablavar (previously Vasovist)

Withdrawn

This medicine's authorisation has been withdrawn

gadofosveset trisodium

Overview

The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.

Ablavar: EPAR - Summary for the public

Product information

Ablavar: EPAR - Product Information

Latest procedure affecting product information: IB/0020

15/05/2011

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).

Ablavar : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ablavar (previously Vasovist)
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000601
• Marketing authorisation holder:
  TMC Pharma Services Ltd.

  Finchampstead; Berkshire RG40 4LJ; United Kingdom

• Marketing authorisation issued:
  03/10/2005
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Ablavar : EPAR - Procedural steps taken and scientific information after authorisation

Vasovist-H-C-601-A-20-15: EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/452190/2010

Initial marketing authorisation documents

Vasovist : EPAR - Procedural steps taken before authorisation

Vasovist : EPAR - Scientific Discussion