Dovato
dolutegravir / lamivudine
Table of contents
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.
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List item
Dovato : EPAR - Medicine overview (PDF/121.73 KB)
First published: 04/09/2019
Last updated: 24/04/2020
EMA/276259/2019 -
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List item
Dovato : EPAR - Risk-management-plan summary (PDF/368.76 KB)
First published: 04/09/2019
Last updated: 08/08/2023
Authorisation details
Product details | |
---|---|
Name |
Dovato
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Agency product number |
EMEA/H/C/004909
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR
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Publication details | |
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Marketing-authorisation holder |
ViiV Healthcare B.V.
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
10/06/2022
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Contact address |
Van Asch van Wijckstraat 55 H |
Product information
06/09/2023 Dovato - EMEA/H/C/004909 - IB/0041/G
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.