Dovato

RSS

dolutegravir / lamivudine

Authorised
This medicine is authorised for use in the European Union.

Overview

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 08/11/2022

Authorisation details

Product details
Name
Dovato
Agency product number
EMEA/H/C/004909
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
J05AR
Publication details
Marketing-authorisation holder
ViiV Healthcare B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
10/06/2022
Contact address

Van Asch van Wijckstraat 55 H
3811 LP Amersfoort
The Netherlands

Product information

22/09/2022 Dovato - EMEA/H/C/004909 - WS2334

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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