Freedom of Information request (FOI 22/830)
Published 17 January 2024
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1st August 2022
FOI 22/830
Dear ,
Thank you for your email.
Please note that until 31st December 2020, we were part of the EMA regulatory system, and followed the recommendation of the EC to approve this.
Veklury Remdesivir 100 mg powder for concentrate for solution for infusion (PLGB 11972/0036) was authorised by the European Commission (EC) following a Centralised Procedure on 03 July 2020 (EMEA/H/C/005622), for the treatment of 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.
Further information on this product, including the Public Assessment Report (which details the non-confidential parts of the assessment of this product), is available from the European Medicines Agency via the below link:
https://www.ema.europa.eu/en/medicines/human/EPAR/veklury
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