dolutegravir / lamivudine

This medicine is authorised for use in the European Union.


Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used to treat adults and adolescents over 12 years old who weigh at least 40 kg.

This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.

This EPAR was last updated on 24/04/2020

Authorisation details

Product details
Agency product number
Active substance
  • dolutegravir sodium
  • lamivudine
International non-proprietary name (INN) or common name
  • dolutegravir
  • lamivudine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Date of issue of marketing authorisation valid throughout the European Union

Product information

01/04/2020 Dovato - EMEA/H/C/004909 - WS/1762


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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic 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.

Assessment history

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