Exviera

Withdrawn

This medicine's authorisation has been withdrawn

dasabuvir

Overview

On 25 September 2024, the European Commission withdrew the marketing authorisation for Exviera (dasabuvir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AbbVie Deutschland GmbH & Co. KG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Exviera was granted marketing authorisation in the EU on 15 January 2015 for the treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2019. 

The European Public Assessment Report (EPAR) for Exviera is updated to indicate that the marketing authorisation is no longer valid.

Exviera : EPAR - Summary for the public

Exviera : EPAR - Risk-management-plan summary

Product information

Exviera : EPAR - Product Information

Exviera : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Exviera
• Active substance:
  dasabuvir sodium
• International non-proprietary name (INN) or common name:
  dasabuvir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AP09

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

For hepatitis C virus (HCV) genotype specific activity.

Authorisation details

• EMA product number:
  EMEA/H/C/003837
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Marketing authorisation holder:
  AbbVie Ltd

  Vanwall Business Park, Vanwall Road ; Maidenhead; Berkshire SL6 4UB ; United Kingdom

• Opinion adopted:
  20/11/2004
• Marketing authorisation issued:
  14/01/2015
• Withdrawal of marketing authorisation:
  25/09/2024
• Revision:
  26

Assessment history

Changes since initial authorisation of medicine

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

Exviera : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Exviera-H-C-3837-P46-0021 : EPAR - Assessment report

Adopted Reference Number: EMA/92477/2021

Exviera-H-C-3837-P46-0019 : EPAR - Assessment report

Adopted Reference Number: EMA/CHMP/105448/2019

Exviera-H-C-PSUSA-10363-201801 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/633869/2018

Exviera-H-C-3837-A20-1438 : EPAR - Assessment report - Article 20

Reference Number: EMA/103226/2017

Exviera-H-C-3837-A20-0017 : EPAR - Scientific Conclusion

Exviera-H-C-PSUSA-00010363-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/289707/2016

Initial marketing authorisation documents

Exviera : EPAR - Public assessment report

Adopted Reference Number: EMA/768319/2014

CHMP summary of positive opinion for Exviera

Adopted Reference Number: EMA/CHMP/688227/2014