- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Vitravene has been withdrawn at the request of the marketing authorisation holder.
Product information
30/07/2002
This medicine’s product information is available in all official EU languages.
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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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