Ablavar (previously Vasovist)

Withdrawn

This medicine's authorisation has been withdrawn

gadofosveset trisodium

Overview

On 3 October 2005 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Vasovist (gadofosveset) for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease. The name of the medicinal product was changed to Ablavar on 10 January 2011. The marketing authorisation holder (MAH) responsible for Ablavar was TMC Pharma Services Ltd. 

The European Commission was notified by a letter dated 13 September 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Ablavar for commercial reasons. Ablavar was not marketed in any European country. On 18 October 2011 the European Commission issued a decision to withdraw the marketing authorisation for Ablavar. 

Pursuant to this decision the European Public Assessment Report for Ablavar is updated to reflect that the marketing authorisation is no longer valid.

Ablavar: EPAR - Summary for the public

Product information

Ablavar: EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  18/10/2011
• 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