Zokovea
Authorised
This medicine is authorised for use in the European Union
ensitrelvir
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Zokovea is a medicine for preventing COVID-19 in adults and adolescents 12 years and older who have been exposed to SARS-CoV-2, the virus that causes COVID-19.
It contains the active substance ensitrelvir.
Zokovea is available as tablets taken once a day for five days. Treatment should start as soon as possible and within 3 days of close contact with someone infected with SARS-CoV-2.
The medicine can only be obtained with a prescription.
For more information about using Zokovea, see the package leaflet or contact your healthcare provider.
The active substance in Zokovea, ensitrelvir, stops the activity of a protein called SARS-CoV-2 3C‑like protease, which is necessary for the virus to multiply. By stopping its activity, ensitrelvir reduces the chance of the virus multiplying in sufficient numbers to cause COVID-19.
A main study of 2,387 people showed that Zokovea was effective at preventing COVID-19 in people living with someone who had the illness. Within 10 days of taking the first dose, 3% of those who took Zokovea had symptomatic COVID-19, compared with 9% of those who took placebo (a dummy treatment).
Studies carried out with Zokovea are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Zokovea, see the package leaflet.
The most common side effects with Zokovea (which may affect up to 1 in 10 people) include high blood levels of triglycerides (a type of fat), headache, diarrhoea and nausea (feeling sick).
Zokovea must not be used in pregnant women. It must also not be used in people taking medicines the body clears away using an enzyme known as CYP3A when a high concentration of these medicines could have serious or life-threatening consequences. It must also not be used in people who take medicines that could increase the activity of CYP3A (CYP3A inducers), as these could reduce the effectiveness of Zokovea. For more information about these medicines, see the package leaflet.
Zokovea is effective at preventing COVID-19 in people exposed to SARS-CoV-2. Its side effects were generally mild to moderate and resolved within a few days.
The European Medicines Agency decided that Zokovea’s benefits are greater than its risks and that it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zokovea have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zokovea are continuously monitored. Suspected side effects reported with Zokovea are carefully evaluated and any necessary action is taken to protect patients.
Zokovea received a marketing authorisation valid throughout the EU on 18 September 2026.
Product information
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).
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
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Post exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older
News on Zokovea
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