🇪🇺 APRETUDE in European Union

EMA authorised APRETUDE on 15 September 2023

Marketing authorisation

EMA — authorised 15 September 2023

  • Application: EMEA/H/C/005756
  • Marketing authorisation holder: ViiV Healthcare B.V.
  • Local brand name: Apretude
  • Indication: Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).
  • Status: approved

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APRETUDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is APRETUDE approved in European Union?

Yes. EMA authorised it on 15 September 2023.

Who is the marketing authorisation holder for APRETUDE in European Union?

ViiV Healthcare B.V. holds the EU marketing authorisation.