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 adolescents (from 12 years of age and weighing at least 40 kilograms) 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 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 28/03/2022

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.

Conditional approvalConditional approval

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.

Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
10
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

03/02/2022 Veklury - EMEA/H/C/005622 - II/0026/G

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 adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)
  • adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19

Assessment history

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