Vitravene

RSS

fomivirsen

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vitravene has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 07/08/2002

Authorisation details

Product details
Name
Vitravene
Agency product number
EMEA/H/C/000244
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
Publication details
Marketing-authorisation holder
Novartis Ophthalmics Europe Ltd.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
29/07/1999
Contact address
Delta House, Southwood Crescent
Southwood, Farnborough
Hants, GU14 0NL
United Kingdom

Product information

30/07/2002 Vitravene - EMEA/H/C/000244 -

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic 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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