- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 26 March 2021, the European Commission withdrew the marketing authorisation for Crixivan (indinavir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Crixivan was granted marketing authorisation in the EU on 04 October 1996 for treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults in combination with antiretroviral nucleoside analogues. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2001 and 2006. It was then granted unlimited validity in 2011. The product had not been marketed in the EU since 2020.
The European Public Assessment Report (EPAR) for Crixivan is updated to indicate that the marketing authorisation is no longer valid.
Product information
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
- Crixivan
- Active substance
- indinavir sulfate ethanolate
- International non-proprietary name (INN) or common name
- indinavir
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AE02
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.