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.

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.

This EPAR was last updated on 30/11/2020

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
2
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

29/09/2020 Veklury - EMEA/H/C/005622 - IB/0004

Contents

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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 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen. 

Assessment history

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