Ablavar (previously Vasovist)
Withdrawn
This medicine's authorisation has been withdrawn
gadofosveset trisodium
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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decision the European Public Assessment Report for Ablavar is updated to reflect that the marketing authorisation is no longer valid.
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).
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 mediaTherapeutic 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.
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