Human medicines European public assessment report (EPAR): Zokovea, ensitrelvir, Status: Opinion
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zokovea, intended for the post-exposure prophylaxis of COVID-19.
The applicant for this medicinal product is Shionogi B.V.
Zokovea will be available as 125 mg tablets. The active substance of Zokovea is ensitrelvir, an antiviral for systemic use (ATC code: J05AE16), which acts through selective inhibition of the SARS-CoV-2 3C-like protease, thereby inhibiting viral replication.
The benefit of Zokovea is a reduced risk of symptomatic COVID-19 in household contacts of an individual with COVID-19 when administered within 72 hours after index patient symptom onset, as observed in a multicentre, double-blind, randomised, placebo-controlled study evaluating efficacy and safety.
The most common side effects are hypertriglyceridaemia, headache, diarrhoea and nausea.
The full indication is:
Zokovea is indicated for the post‑exposure prophylaxis of COVID‑19 in adults and adolescents aged 12 years and older. Zokovea should be used in accordance with official recommendations.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
CHMP summary of positive opinion for Zokovea
Adopted
Reference Number:
EMADOC-1829012207-58529
English (EN) (118.93 KB - PDF)
First published:
24/07/2026
View
Product details
Name of medicine
Zokovea
Active substance
ensitrelvir fumaric acid
International non-proprietary name (INN) or common name
ensitrelvir
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J05AE16
EMA product number
EMEA/H/C/006063
Marketing authorisation applicant
Shionogi B.V.
Opinion adopted
23/06/2026
Opinion status
Positive
News on Zokovea
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026
24/07/2026
This page was last updated on
24/07/2026
Summary
On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zokovea, intended for the post-exposure prophylaxis of COVID-19. The applicant for this medicinal product is Shionogi B.V. Zokovea will be available as 125 mg tablets. The active substance of Zokovea is ensitrelvir, an antiviral for systemic use (ATC code: J05AE16), which acts through selective inhibition of the SARS-CoV-2 3C-like protease, thereby inhibiting viral replication. The benefit of Zokovea is a reduced risk of symptomatic COVID-19 in household contacts of an individual with COVID-19 when administered within 72 hours after index patient symptom onset, as observed in a multicentre, double-blind, randomised, placebo-controlled study evaluating efficacy and safety. The most common side effects are hypertriglyceridaemia, headache, diarrhoea and nausea. The full indication is: Zokovea is indicated for the post‑exposure prophylaxis of COVID‑19 in adults and adolescents aged 12 years and older. Zokovea should be used in accordance with official recommendations. Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.