Vitravene
Withdrawn
This medicine's authorisation has been withdrawn
fomivirsen
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 29 July 1999, the European Commission granted a marketing authorisation for the whole European Union to CIBA Vision Europe Ltd. (on 5 March 2001, the name of the Marketing Authorisation Holder (MAH) changed to Novartis Ophthalmics Europe Ltd) for Vitravene (fomivirsen), indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).
On 23 May 2002, the MAH notified the European Commission of his decision to voluntarily withdraw the Marketing Authorisation for Vitravene. The MAH confirmed that this decision was based on commercial reasons and not due to any safety-related concerns. Vitravene is still authorised in Switzerland and the MAH will be able to supply Vitravene to European Member States from Switzerland on a named patient basis. According to the MAH, the demand for Vitravene is less than 100 units/year. Therefore, the MAH believes that withdrawal of Vitravene will have no negative impact on patients in Europe.
On 30 July 2002, the European Commission adopted a decision withdrawing the Marketing Authorisation for the medicinal product for human use “Vitravene”. Pursuant to this decision, the European Public Assessment Report for Vitravene has been removed from this website.
Product information
30/07/2002
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
- Vitravene
- Active substance
- fomivirsen
- International non-proprietary name (INN) or common name
- fomivirsen
- Therapeutic area (MeSH)
- Cytomegalovirus Retinitis
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- S01AD08
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
For the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immuno-deficiency syndrome (AIDS).
Until further experience is gained, fomivirsen should be used only when other therapy has been ineffective or is considered unsuitable.
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