Vistide

Withdrawn

This medicine's authorisation has been withdrawn

cidofovir

Overview

The marketing authorisation for Vistide has been withdrawn at the request of the marketing authorisation holder.

Vistide : EPAR - Summary for the public

Product information

Vistide : EPAR - Product Information

Latest procedure affecting product information: N/0034

22/08/2014

This medicine’s product information is available in all official EU languages.
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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).

Vistide : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Vistide
• Active substance:
  cidofovir
• International non-proprietary name (INN) or common name:
  cidofovir
• Therapeutic area (MeSH):
  Cytomegalovirus Retinitis
• Anatomical therapeutic chemical (ATC) code:
  J05AB12

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000121
• Marketing authorisation holder:
  Gilead Sciences International Limited

  Cambridge; CB21 6GT; United Kingdom

• Marketing authorisation issued:
  23/04/1997
• Revision:
  21

Assessment history

Changes since initial authorisation of medicine

Vistide : EPAR - Procedural steps taken and scientific information after authorisation

Vistide-H-C-121-A20-35 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/303411/2012

Vistide : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Vistide : EPAR - Procedural steps taken before authorisation

Vistide : EPAR - Scientific Discussion