Veklury is an antiviral medicine used to treat coronavirus disease 2019 (COVID-19). It is used in adults and children, from 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 the start of treatment).
The medicine can also be used in adults and children (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.
Veklury contains the active substance remdesivir.
Veklury : EPAR - Medicine overview (PDF/126.21 KB)
First published: 06/07/2020
Last updated: 12/12/2022
Veklury : EPAR – Risk management plan (PDF/2.08 MB)
First published: 22/07/2020
Last updated: 23/09/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
IDA Business & Technology Park
05/01/2023 Veklury - EMEA/H/C/005622 - II/0043
This medicine’s product information is available in all official EU languages.
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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.
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) 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
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 202216/09/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 202117/12/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 202002/10/2020