Is Fomivirsen approved by the US FDA?

Drugs@FDA lists 1 application product line for Fomivirsen, including VITRAVENE PRESERVATIVE FREE (Discontinued).

Is Fomivirsen authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Fomivirsen.

Active substance

Fomivirsen

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VITRAVENE PRESERVATIVE FREE	6.6MG/ML	injectable · injection	NOVARTIS	Discontinued	26 Aug 1998

EMA European Union — centrally authorised medicines

Vitravene Novartis Ophthalmics Europe Ltd. · Withdrawn · authorised 29 Jul 1999 · ATC S01AD08

Therapeutic indication (EMA)

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.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.