🇪🇺 nPEP in European Union

EMA authorised nPEP on 21 June 2018

Marketing authorisation

EMA — authorised 21 June 2018

  • Application: EMEA/H/C/004449
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Biktarvy
  • Indication: Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)
  • Status: approved

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nPEP 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 nPEP approved in European Union?

Yes. EMA authorised it on 21 June 2018.

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

Gilead Sciences Ireland UC holds the EU marketing authorisation.