Veklury
remdesivir
Table of contents
Overview
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.
-
List item
Veklury : EPAR - Medicine overview (PDF/126.21 KB)
First published: 06/07/2020
Last updated: 12/12/2022
EMA/791331/2022 -
-
List item
Veklury : EPAR – Risk management plan (PDF/1.36 MB)
First published: 22/07/2020
Last updated: 19/10/2023
Authorisation details
Product details | |
---|---|
Name |
Veklury
|
Agency 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. |
Publication details | |
---|---|
Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
03/07/2020
|
Contact address |
IDA Business & Technology Park |
Product information
12/10/2023 Veklury - EMEA/H/C/005622 - II/0050
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Therapeutic indication
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
Assessment history
News
-
09/12/2022
-
16/09/2022
-
17/12/2021
-
23/02/2021
-
12/02/2021
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 202011/12/2020
-
20/11/2020
-
02/10/2020
-
26/06/2020
-
25/06/2020