Mexico City.- Cofepris announced the authorization of the health registration of Paxlovid (nirmatrelvir/ritonavir), from the Pfizer laboratory, indicated to treat Covid-19 in adults who do not require supplemental oxygen and who have a higher risk of progression to a serious condition.
This supports the open marketing of the first drug to prevent hospitalizations and mortality from coronavirus, the agency reported.
According to Cofepris, the decision is based on the evaluation of the Committee for New Molecules and the rigorous technical analysis carried out by the agency’s specialized team, who determined that the drug meets the requirements of quality, safety and efficacy.
This drug has already been approved by regulatory authorities such as the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), as well as entities in Latin America such as the National Health Surveillance Agency of Brazil (Anvisa) and the National Medicines Agency of Chile (Anamed).
Paxlovid administration requires a medical prescription. Health professionals should evaluate the use and risk factors detailed in the authorization letter to avoid misuse, self-medication and irregular sales.
This medicine must be administered under strict medical supervision.
“The sanitary registration of Paxlovid is the result of extensive proactive regulatory work by this health agency, in addition to collaboration with the manufacturing laboratory,” Cofepris highlighted.
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