Rezolsta - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

darunavir / cobicistat

Opinion

On 22 May 2025, 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 NV.

The CHMP adopted an extension to the existing indication, as follows:¹

Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and adolescentspaediatric patients (aged 12 6 years and older, weighing at least 4025 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.

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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Rezolsta (X-54-G)

AdoptedReference Number: EMA/CHMP/162393/2025

Key facts

• Name of medicine:
  Rezolsta
• EMA product number:
  EMEA/H/C/002819
• Active substance:
  • darunavir
  • cobicistat
• International non-proprietary name (INN) or common name:
  • darunavir
  • cobicistat
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutical chemical (ATC) code:
  J05
• Marketing authorisation holder:
  Janssen-Cilag International N.V.
• Date of opinion:
  22/05/2025
• Status:
  Positive