EMA — authorised 17 August 2022
- Marketing authorisation holder: GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- Status: approved
🇪🇺 Sunlenca in European Union
EMA authorised Sunlenca on 17 August 2022
Marketing authorisations
EMA — authorised 25 August 2025
- Application: EMEA/H/C/006658
- Marketing authorisation holder: Gilead Sciences Ireland Unlimited Company
- Local brand name: Yeytuo
- Indication: Yeytuo tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV 1 acquisition risk, weighing at least 35 kg for: oral loading oral bridging (see sections 4.2, 4.4 and 5.1)
- Status: approved
The European Medicines Agency (EMA) has approved Yeytuo (Sunlenca) for use in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. This approval is for adults and adolescents with increased HIV-1 acquisition risk, weighing at least 35 kg. The medication is indicated for oral loading and oral bridging, as specified in the product information.
Sunlenca in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Sunlenca approved in European Union?
Yes. EMA authorised it on 17 August 2022; EMA authorised it on 25 August 2025.
Who is the marketing authorisation holder for Sunlenca in European Union?
GILEAD SCIENCES IRELAND UNLIMITED COMPANY holds the EU marketing authorisation.