Fortovase

RSS

saquinavir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Fortovase has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 07/08/2006

Authorisation details

Product details
Name
Fortovase
Agency product number
EMEA/H/C/000178
Active substance
saquinavir
International non-proprietary name (INN) or common name
saquinavir
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AE01
Publication details
Marketing-authorisation holder
Roche Registration Ltd.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
20/08/1998
Contact address
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

20/08/1998 Fortovase - EMEA/H/C/000178 -

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

Fortovase is indicated for treatment of HIV-1 infected adult patients. Fortovase should only be given in combination with ritonavir and other antiretroviral medicinal products (see section 4.2).

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