Veklury - opinion on variation to marketing authorisation

Opinion

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

remdesivir

Opinion

On 25 April 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 Veklury. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.

The CHMP adopted an extension to an existing indication to include treatment of children of at least 4 weeks of age and weighing at least 3 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The indication for Xofluza will therefore be as follows:¹

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg): 

• adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)
• adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19

(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.

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¹ New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Veklury (II-53-G)

AdoptedReference Number: EMA/CHMP/118124/2025

Key facts

• Name of medicine:
  Veklury
• EMA product number:
  EMEA/H/C/005622
• Active substance:
  remdesivir
• International non-proprietary name (INN) or common name:
  remdesivir
• Therapeutic area (MeSH):
  COVID-19 virus infection
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Gilead Sciences Ireland UC
• Date of opinion:
  25/04/2025
• Status:
  Positive