Dovato - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
dolutegravir / lamivudine
Post-authorisationHuman
On 12 November 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product Dovato. The marketing authorisation holder for this medicinal product is ViiV Healthcare B.V.
The CHMP adopted a new indication associated with new Dovato 5 mg / 30 mg dispersible tablets, as follows:
Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in children at least 3 months of age, weighing at least 6 kg to less than 25 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine (see section 5.1).
The CHMP also adopted an extension to the existing indication for Dovato 50 mg / 300 mg film-coated tablets, as follows:
Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults, and adolescents and children above 12 years of age weighing at least 2040 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine (see section 5.1).
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold, removed text as strikethrough.
CHMP post-authorisation summary of positive opinion for Dovato (X-0000335457)
Adopted
Reference Number: EMADOC-1700519818-3531355
English (EN) (129.36 KB - PDF)
Pubblicato per la prima volta: