Invirase

Withdrawn

This medicine's authorisation has been withdrawn

saquinavir

Overview

On 16 August 2023, the European Commission withdrew the marketing authorisation for Invirase (saquinavir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Roche Registration GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Invirase was granted marketing authorisation in the EU on 4 October 1996 for the treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was granted unlimited validity in 2006. 

The European Public Assessment Report (EPAR) for Invirase is updated to indicate that the marketing authorisation is no longer valid.

Invirase : EPAR - Summary for the public

Product information

Invirase : EPAR - Product Information

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

• Opinion adopted:
  23/07/2009
• Marketing authorisation issued:
  03/10/1996
• Withdrawal of marketing authorisation:
  16/08/2023
• 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

Adopted Reference Number: EMA/129533/2013

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

Adopted Reference Number: EMA/58070/2011

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

Adopted Reference 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