🇪🇺 Dolutegravir/Lamivudine in European Union

EMA authorised Dolutegravir/Lamivudine on 1 July 2019

Marketing authorisation

EMA — authorised 1 July 2019

  • Application: EMEA/H/C/004909
  • Marketing authorisation holder: ViiV Healthcare B.V.
  • Local brand name: Dovato
  • Indication: Dovato is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.
  • Status: approved

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Dolutegravir/Lamivudine 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 / Virology approved in European Union

Frequently asked questions

Is Dolutegravir/Lamivudine approved in European Union?

Yes. EMA authorised it on 1 July 2019.

Who is the marketing authorisation holder for Dolutegravir/Lamivudine in European Union?

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