The collegiate board of Anvisa (National Health Surveillance Agency) approved the emergency use of the Pfizer pill for Covid-19. The treatment will be sold under the name Paxlovid.
The pill is composed of nirmatrelvir and ritonavir tablets, and is indicated for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of progression to the severe form of the disease.
The regulatory agency said that all scientific evidence, risks and benefits of the drug were evaluated in the emergency use authorization protocol.
The pill is not authorized for initiation of treatment in patients who require hospitalization due to severe or critical manifestations of Covid-19. It is also not authorized for pre- or post-exposure prophylaxis to prevent infection.
The drug is also not authorized for use for more than five days. In addition, as there are no data on the use of the pill in pregnant women, it is recommended that pregnancy be avoided during treatment with the drug and, as a preventive measure, up to seven days after the end of treatment.
Pfizer said in December last year that the final analysis of its Covid antiviral pill showed nearly 90% effectiveness in preventing hospitalizations and deaths in high-risk patients. In addition, laboratory data suggest that the drug retains its effectiveness against the fast-spreading omicron variant of the coronavirus.
The Ministry of Health evaluates the use of the drug in the SUS (Unified Health System).
The drug already has approval for emergency use in the United States, Europe, Canada, China, Australia, Japan, the United Kingdom and Mexico.
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