Invirase
Withdrawn
This medicine's authorisation has been withdrawn
saquinavir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Invirase is updated to indicate that the marketing authorisation is no longer valid.
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).
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 useTherapeutic 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.
News on Invirase
Topics
This page was last updated on