The Brazilian Health Regulatory Agency (ANVISA) issued the regulation RDC No. 752/2022 .


The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.


Brazil’s National Health Surveillance Agency (Anvisa) has approved a new indication for the drug Veklury (remdesivir) for the treatment of Covid-19. The approved indication is for adult patients who do not require supplemental oxygen administration and who are at increased risk of progressing to a severe case of Covid-19.

new therapeutic indication

This is a new therapeutic indication, since remdesivir is registered in Brazil for the treatment of Covid-19 only in adult and adolescent patients (aged 12 years or older and with a body weight of at least 40 kg) with pneumonia requiring supplemental oxygen administration (low-flow or high-flow oxygen or other noninvasive ventilation at the beginning of treatment).

When to use the Medication?

Treatment for the new indication should be started as soon as possible after Covid-19 is diagnosed and within seven days of the onset of symptoms. The total duration of treatment should be three days. The recommendation is a single dose of 200 mg remdesivir on the first day, administered by intravenous infusion, and 100 mg on the following days, once a day, also by intravenous infusion.

The same safety conditions for outpatient administration of the drug, already established in the Veklury package insert, should be maintained, such as liver and kidney laboratory tests in all patients before the start of treatment.

What is Remdesivir?

Remdesivir is an injectable antiviral produced as a dilution powder in 100 mg vials. The substance prevents the virus from replicating in the body, slowing down the infection process.

For the inclusion of the new indication, the company Gilead Sciences Farmacêutica do Brasil Ltda. presented clinical data demonstrating the efficacy and safety of the drug for the respective purpose.

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