Overview:

Brazil Anvisa authorizes Remdesivir for pediatric use in the treatment of Covid-19. Anvisa approved, on Monday (11/21/2022) the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.

Introduction:

Remdesivir is an injectable antiviral produced in powder form for dilution, in 100 mg vials. The antiviral was registered by Anvisa on March 12 last year and is indicated for the treatment of Covid
The substance prevents the virus from replicating in the body, slowing down the infection process. In other words, it acts only therapeutically, is not effective for preventing the virus and does not replace the vaccine.
The decision was based on clinical data presented by the company, considering that these studies have shown clinical benefit, besides there being no new concerns about the safety of the drug, which has no contraindications or side effects.

Restriction on the place of use

Despite the approval, the restriction on the place of use does not change: the application is made only in hospital visits, and it is not possible to buy Remdesivir in pharmacies.

The approval includes the following population:

  • infants and children 28 days and older and weighing 3 kg or more with pneumonia who require supplemental oxygen administration (low or high flow oxygen, or other non-invasive ventilation at the start of treatment);
  • children weighing ≥ 40 kg who do not require supplemental oxygen administration and who are at increased risk of progressing to severe Covid-19.

Learn more about Remdesivir regulations:

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