Crixivan

Withdrawn

This medicine's authorisation has been withdrawn

indinavir

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The European Public Assessment Report (EPAR) for Crixivan is updated to indicate that the marketing authorisation is no longer valid.

Crixivan : EPAR - Summary for the public

Reference Number: EMA/721612/2016

Product information

Crixivan : EPAR - Product Information

Crixivan : EPAR - All Authorised presentations

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 use

Therapeutic indication

Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.

Authorisation details

• EMA product number:
  EMEA/H/C/000128
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Marketing authorisation issued:
  04/10/1996
• Revision:
  39

Assessment history

Changes since initial authorisation of medicine

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

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

Initial marketing authorisation documents

Crixivan : EPAR - Scientific Discussion

Crixivan : EPAR - Procedural steps taken before authorisation