Rezolsta - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
darunavir / cobicistat
Post-authorisationHuman
On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Rezolsta. The marketing authorisation holder for this medicinal product is Janssen-Cilag International N.V.
The CHMP adopted a new pharmaceutical form, dispersible tablets, associated with a new strength (600 mg / 90 mg) and a new indication to include children from 3 years of age weighing at least 15 kg, as follows:
Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and paediatric patients aged 3 years and older, weighing at least 15 kg.
Genotypic testing should guide the use of Rezolsta (see sections 4.2, 4.4 and 5.1).
For information, the indication for Rezolsta film-coated tablets remains unchanged, as follows:
Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and paediatric patients aged 6 years and older, weighing at least 25 kg.
Genotypic testing should guide the use of Rezolsta (see sections 4.2, 4.4 and 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.
CHMP post-authorisation summary of positive opinion for Rezolsta (X-0000268372)
Reference Number: EMADOC-1700519818-3224353
English (EN) (188.33 KB - PDF)
First published: