Vistide

RSS

cidofovir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vistide has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 19/01/2015

Authorisation details

Product details
Name
Vistide
Agency product number
EMEA/H/C/000121
Active substance
cidofovir
International non-proprietary name (INN) or common name
cidofovir
Therapeutic area (MeSH)
Cytomegalovirus Retinitis
Anatomical therapeutic chemical (ATC) code
J05AB12
Publication details
Marketing-authorisation holder
Gilead Sciences International Limited
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
23/04/1997
Contact address
Cambridge
CB21 6GT
United Kingdom

Product information

22/08/2014 Vistide - EMEA/H/C/000121 - N/0034

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

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.

Assessment history

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