Vitrasert Implant

RSS

ganciclovir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Vitrasert Implant has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 13/05/2002

Authorisation details

Product details
Name
Vitrasert Implant
Agency product number
EMEA/H/C/000120
Active substance
ganciclovir
International non-proprietary name (INN) or common name
ganciclovir
Therapeutic area (MeSH)
  • Cytomegalovirus Retinitis
  • HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AB06
Publication details
Marketing-authorisation holder
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
18/03/1997
Contact address
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbuetteler Damm 165-173
D-13581Berlin (Spandau)
Germany

Product information

02/04/2002 Vitrasert Implant - EMEA/H/C/000120 -

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

The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).

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