Cofepris authorizes open marketing of Paxlovid, indicated for the treatment of Covid – 19

A prescription is required. Health professionals must evaluate the use and risk factors detailed in the authorization letter to avoid misuse, self-medication and irregular sales..

Sicom News

In compliance with its total commitment to the health of the Mexican population, the Federal Commission for the Protection against Sanitary Risks (Cofepris) authorized the sanitary registration of Paxlovid (nirmatrelvir/ritonavir), from the Pfizer laboratory, indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who have a higher risk of progression to severe COVID-19.

The decision is based on the evaluation of the Committee for New Molecules (CMN) and the rigorous technical analysis carried out by the agency’s specialized team, who determined that the drug meets the quality, safety and efficacy requirements, according to the information presented in the technical file. Thanks to these results, the open marketing of the first drug to prevent hospitalizations and mortality due to COVID-19 is authorized, making Cofepris one of the first regulatory agencies to authorize Paxlovid for this type of health registration.

This drug has already been approved by leading 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). The authorization in Mexico will allow for continued progress in the fight against COVID-19.

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.

The supply of this medicine must be carried out under strict medical supervision. Therefore, Cofepris urges the population to avoid the indiscriminate use of vaccines or treatments against COVID-19, since their incorrect application can represent health risks. In case of any adverse event, it must be reported in the following link.

Paxlovid’s health registration is the result of extensive proactive regulatory work by this health agency, in addition to collaboration with the manufacturing laboratory, in order to expand the treatment options available for COVID-19.

Cofepris joins the international call to remind the population that this treatment does not replace the authorized vaccines against COVID-19 and that it should not be used without medical advice.

In case of identifying its free sale to the public, Cofepris invites citizens to present health report. The irregular marketing of this medicine can put public health at risk, so it is important to report any anomaly to ensure its proper use.