Freedom of Information request on the product Remdesivir (FOI 22/789)
Published 21 December 2023
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FOI 22/789
15th July 2022
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
Regarding the specific questions, please see responses in red:
1.Who recommended Remdesivir to be given EUA for Treatment for Covid-19 patients
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
2.Did the manufacturer Merck go to MHRA to recommend Remdesivir
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
3.Was it NHS who recommended Remdesivir to be use to Treat covid-19
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
4.Which person in MHRA give the EUA to Remdesivir was the Bosses decision
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
5.was it the Government Covid-19 task force that recommended Remdesivir to be given to be Re-purposed to treat Covid-19 patients like
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
6.Did any US NIH FDA CDC contact MHRA about to use Remdesivir or any other drug to treat covid-19 or to give EUA
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
7.they so much Controversy Surrounding Remdesivir the high cost / failure in Ebola trials its dangerous drug and it kills
Why did MHRA give EUA to Remdesivir
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
8.Might be similar to questions 1.
But who approached MHRA that possibility that Remdesivir could be used to treat covid-19 patients then who ask it to be given EUA status
- As stated above, the authorisation of Veklury Remdesivir 100 mg powder for concentrate for solution for infusion was recommended following a Centralised Procedure by the European Commission.
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Yours sincerely
MHRA Customer Experience Centre