🇪🇺 FOMIVIRSEN in European Union

EMA authorised FOMIVIRSEN on 29 July 1999

Marketing authorisation

EMA — authorised 29 July 1999

  • Application: EMEA/H/C/000244
  • Marketing authorisation holder: Novartis Ophthalmics Europe Ltd.
  • Local brand name: Vitravene
  • 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.
  • Status: withdrawn

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FOMIVIRSEN in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is FOMIVIRSEN approved in European Union?

Yes. EMA authorised it on 29 July 1999.

Who is the marketing authorisation holder for FOMIVIRSEN in European Union?

Novartis Ophthalmics Europe Ltd. holds the EU marketing authorisation.