Veklury

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remdesivir

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 09/01/2023

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)
Coronavirus Infections
Additional monitoringAdditional 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
16
Date of issue of marketing authorisation valid throughout the European Union
03/07/2020
Contact address

IDA Business & Technology Park
Carrigtohill
County Cork
T45 DP77
Ireland

Product information

05/01/2023 Veklury - EMEA/H/C/005622 - II/0043

Other EU languages available icon 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:

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

Not yet assigned

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

Changes since initial authorisation of medicine

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