Fortovase

Withdrawn

This medicine's authorisation has been withdrawn

saquinavir

Overview

The marketing authorisation for Fortovase has been withdrawn at the request of the marketing authorisation holder.

Product information

20/08/1998

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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).

Product details

• Name of medicine:
  Fortovase
• Active substance:
  saquinavir
• International non-proprietary name (INN) or common name:
  saquinavir
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AE01

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000178
• Marketing authorisation holder:
  Roche Registration Ltd.

  Roche Registration Limited; 6 Falcon Way; Shire Park; Welwyn Garden City; AL7 1TW; United Kingdom

• Marketing authorisation issued:
  20/08/1998
• Revision:
  11