Veklury (remdesivir)
- Region
- 🇪🇺 EU
- Active substance
- remdesivir
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 25 Jun 2020
- EU approval
- Fri 03 Jul 2020
- Application
- EMEA/H/C/005622
- ATC
- J05AB16
- Official record
- www.ema.europa.eu
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) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1)
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.