Roche withdraws Invirase (saquinavir) EU Marketing Authorization for HIV-1 Infection

The EMA reported on September 4, 2025 that 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European Public Assessment Report (EPAR) for Invirase will be updated to indicate that the marketing authorisation is no longer valid.

Document source: public-statement-invirase-withdrawal-marketing-authorisation-european-union_en.pdf