<p>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. </p><p>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 The European Public Assessment Report (EPAR) for Viekirax is updated to indicate that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.</p> <p>For hepatitis C virus (HCV) genotype specific activity.</p></div>
Therapeutic Area (MeSH)
ATC Code
J05AP53
ATC Item
N/A
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| ombitasvir | N/A | ombitasvir |
| paritaprevir | N/A | paritaprevir |
| ritonavir | N/A | ritonavir |
EMA Name
Viekirax
Medicine Name
Viekirax
Aliases
N/ANo risk management plan link.
