Veklury is an antiviral medicine used to treat coronavirus disease 2019 (COVID-19). It is used in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) with pneumonia requiring supplemental oxygen.
COVID-19, which is caused by SARS-CoV-2 virus, was declared a pandemic by the World Health Organization on 11 March 2020.
Veklury contains the active substance remdesivir.
Veklury : EPAR - Medicine overview (PDF/121.23 KB)
First published: 06/07/2020
Last updated: 22/07/2020
Veklury : EPAR – Risk management plan (PDF/1.4 MB)
First published: 22/07/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
Gilead Sciences Ireland UC
|Date of issue of marketing authorisation valid throughout the European Union||
29/09/2020 Veklury - EMEA/H/C/005622 - IB/0004
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 202002/10/2020