Invirase

Withdrawn

This medicine's authorisation has been withdrawn

saquinavir

Overview

The marketing authorisation for Invirase (SRD) has been withdrawn at the request of the marketing-authorisation holder.

Invirase : EPAR - Summary for the public

Product information

Invirase : EPAR - Product Information

Latest procedure affecting product information: N/0139

10/03/2023

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

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).

Invirase : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Invirase
• 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

Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.

Authorisation details

• EMA product number:
  EMEA/H/C/000113
• Marketing authorisation holder:
  Roche Registration GmbH

  Emil-Barell-Strasse 1; 79639 Grenzach-Wyhlen; Germany

• Marketing authorisation issued:
  03/10/1996
• Revision:
  50

Assessment history

Changes since initial authorisation of medicine

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

Invirase-H-C-113-P46-54 : EPAR - Assessment Report

AdoptedReference Number: EMA/129533/2013

Invirase-H-C-113-A20-88 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/58070/2011

Invirase-H-C-113-II-85: EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/623173/2010

Invirase-H-C-113-II-62 : EPAR - Assessment Report - Variation

Invirase-H-C-113-X-43 : EPAR - Assessment Report - Extension

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

Initial marketing authorisation documents

Committee for medicinal products for human use, summary of positive opinion for Lamivudine Teva

Reference Number: EMEA/CHMP/436960/2009

Invirase : EPAR - Scientific Discussion

Invirase : EPAR - Procedural steps taken before authorisation