The marketing authorisation for Vistide has been withdrawn at the request of the marketing authorisation holder.
Vistide : EPAR - Summary for the public (PDF/500.99 KB)
First published: 27/01/2009
Last updated: 19/01/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gilead Sciences International Limited
|Date of issue of marketing authorisation valid throughout the European Union||
22/08/2014 Vistide - EMEA/H/C/000121 - N/0034
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Antivirals for systemic use
Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 201217/02/2012
European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories16/02/2012
European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories13/12/2011
European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories09/12/2011
European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011