Powder for concentrate for solution for infusion for the treatment of COVID-19

About the medicinal product

The medicinal product Veklury contains the active substance remdesivir. It is supplied as a powder for concentrate for solution for injection. The medicine is injected into the veins.

Veklury is an antiviral medicine (antiviral agent). It is used for the treatment of COVID-19, which is caused by coronavirus.

Swissmedic granted Veklury temporary authorisation on 25 November 2020 for the treatment of patients in hospital with pneumonia who require extra oxygen.

On 24 May 2022, Veklury was also authorised for the treatment of adults with a disease caused by COVID-19 who do not require extra oxygen and who are at increased risk of progression to severe disease.

A further indication extension was authorised on 5 April 2023 for the treatment of children aged four weeks and older with a body weight of at least 3 kg with pneumonia requiring additional oxygen (low-flow or high-flow oxygen or other non-invasive ventilation at the start of treatment). The indication extension also means that Veklury has been authorised for adults and children with a body weight of at least 40 kg who have been infected with coronavirus and are at risk of progression to severe COVID-19. These patients do not require extra oxygen or in-patient care in hospital.

As a result of this indication extension, Veklury can be used to treat children aged four weeks and older with a body weight of at least 3 kg who do not require additional oxygen or hospitalisation due to COVID-19 and who are at increased risk of developing a severe form of COVID-19.

In deciding whether to authorise the indication extension for the medicinal product Veklury, Swissmedic took into account the assessments of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of foreign authorities, the preconditions for a SwissPAR (Swiss Public Assessment Report) and a resulting Summary Report on authorisation are not met. Swissmedic refers to the authorisation of the foreign reference authorities.
www.ema.europa.eu
www.fda.gov

Further information on the medicinal product

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^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}