Vitravene

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Withdrawn

This medicine's authorisation has been withdrawn

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The marketing authorisation for Vitravene has been withdrawn at the request of the marketing authorisation holder.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

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.

Authorisation details

EMA product number
EMEA/H/C/000244
Marketing authorisation holder
Novartis Ophthalmics Europe Ltd.

Delta House, Southwood Crescent
Southwood, Farnborough
Hants, GU14 0NL
United Kingdom

Marketing authorisation issued
29/07/1999
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