Viekirax

Withdrawn

This medicine's authorisation has been withdrawn

ombitasvir / paritaprevir / ritonavir

Overview

On 25 September 2024, the European Commission withdrew the marketing authorisation for Viekirax (ombitasvir / paritaprevir / ritonavir) 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. 

Viekirax was granted marketing authorisation in the EU on 15 January 2015 for 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 The European Public Assessment Report (EPAR) for Viekirax is updated to indicate that the marketing authorisation is no longer valid.

Viekirax : EPAR - Medicine overview

Reference Number: EMA/733678/2014

Viekirax : EPAR - Risk-management-plan summary

Product information

Viekirax : EPAR - Product Information

Viekirax : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Viekirax
• Active substance:
  • Ombitasvir
  • paritaprevir
  • ritonavir
• International non-proprietary name (INN) or common name:
  • ombitasvir
  • paritaprevir
  • ritonavir
• Therapeutic area (MeSH):
  Hepatitis C, Chronic
• Anatomical therapeutic chemical (ATC) code:
  J05AP53

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Viekirax 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/003839
• Marketing authorisation holder:
  AbbVie Deutschland GmbH Co. KG

  Knollstrasse; 67061 Ludwigshafen; Germany

• Opinion adopted:
  20/11/2014
• Marketing authorisation issued:
  14/01/2015
• Withdrawal of marketing authorisation:
  25/09/2024
• Revision:
  28

Assessment history

Changes since initial authorisation of medicine

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

Viekirax-H-C-PSUV/SA/Art 20/Art 107i/Art 3 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Viekirax-H-C-3839-P46-023 : EPAR - Assessment report

Adopted Reference Number: EMA/92477/2021

Viekirax-H-C-3839-P46-0021 : EPAR - Assessment report

Adopted Reference Number: EMA/CHMP/105448/2019

Viekirax-H-C-PSUSA-10367-201801 : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/633999/2018

CHMP post-authorisation summary of positive opinion for Viekirax (WS-1348)

Adopted Reference Number: EMA/CHMP/500340/2018

Viekirax-H-C-3839-A20-0018 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/103226/2017

Viekirax-H-C-3839-A20-0018 : EPAR - Scientific Conclusion

Viekirax-H-C-PSUSA-00010367-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/268539/2016

Initial marketing authorisation documents

Viekirax : EPAR - Public assessment report

Adopted Reference Number: EMA/768346/2014

CHMP summary of positive opinion for Viekirax

Adopted Reference Number: EMA/CHMP/688255/2014