Viekirax

Withdrawn

This medicine's authorisation has been withdrawn

ombitasvir / paritaprevir / ritonavir

MedicineHumanWithdrawn

Application under evaluation
CHMP opinion
European Commission decision

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 The European Public Assessment Report (EPAR) for Viekirax is updated to indicate that the marketing authorisation is no longer valid.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

English (EN) (173.05 KB - PDF)

First published: 09/03/2015Last updated: 02/10/2024

Other languages (22)

Viekirax : EPAR - Risk-management-plan summary

English (EN) (272.98 KB - PDF)

First published: 09/03/2015Last updated: 02/10/2024

Product information

Viekirax : EPAR - Product Information

English (EN) (2.59 MB - PDF)

First published: 09/03/2015Last updated: 02/10/2024

Other languages (24)

Latest procedure affecting product information: EMEA/H/C/WS/2430

12/08/2022

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).

Viekirax : EPAR - All Authorised presentations

English (EN) (41.14 KB - PDF)

First published: 09/03/2015Last updated: 02/10/2024

Other languages (24)

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

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

English (EN) (1.5 MB - PDF)

First published: 28/09/2015Last updated: 02/10/2024

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

English (EN) (136.16 KB - PDF)

First published: 07/07/2022Last updated: 02/10/2024

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

AdoptedReference Number: EMA/92477/2021

English (EN) (544.96 KB - PDF)

First published: 01/09/2021Last updated: 02/10/2024

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

AdoptedReference Number: EMA/CHMP/105448/2019

English (EN) (1.94 MB - PDF)

First published: 30/08/2021Last updated: 02/10/2024

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

English (EN) (117.01 KB - PDF)

First published: 11/12/2018Last updated: 02/10/2024

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

AdoptedReference Number: EMA/CHMP/500340/2018

English (EN) (154.42 KB - PDF)

First published: 27/07/2018Last updated: 02/10/2024

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

AdoptedReference Number: EMA/103226/2017

English (EN) (1.19 MB - PDF)

First published: 13/03/2017Last updated: 02/10/2024

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

English (EN) (219.64 KB - PDF)

First published: 13/03/2017Last updated: 02/10/2024

Other languages (22)

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

English (EN) (109.93 KB - PDF)

First published: 25/05/2016Last updated: 02/10/2024

Viekirax : EPAR - Public assessment report

AdoptedReference Number: EMA/768346/2014

English (EN) (7.76 MB - PDF)

First published: 09/03/2015Last updated: 02/10/2024

CHMP summary of positive opinion for Viekirax

AdoptedReference Number: EMA/CHMP/688255/2014

English (EN) (139.1 KB - PDF)

First published: 21/11/2014Last updated: 02/10/2024

News on Viekirax

This page was last updated on 02/10/2024