La Federal Commission for the Protection against Sanitary Risks (Cofepris) authorized this Thursday, August 1, the health 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 are at higher risk of progression to severe COVID-19.
“The decision is based on the evaluation of the Committee on New Molecules (CMN)) and the rigorous technical analysis carried out by the agency’s specialized team, who determined that the drug meets the requirements of quality, safety y effectiveness, 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 from Covid-19 is authorized, making Cofepris one of the first regulatory agencies to authorize Paxlovid for this type of health registration,” it reported in a statement. statement the health agency.
COFEPRIS JOINS FDA AND EMA IN THE SALE OF PAXLOVID
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 us to continue advancing in the fight against Covid-19,” Cofepris indicated.
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. For this reason, Cofepris urged the population to avoid the indiscriminate use of vaccines or treatments against Covid-19, since their incorrect application can pose health risks.
MEDICINE DOES NOT REPLACE VACCINES
“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 against Covid-19.”
Cofepris also issued a warning, explaining that, as recommended by international health agencies, this treatment does not replace the authorized vaccines against Covid-19 and therefore should not be used without a medical indication. N
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The charge Cofepris authorizes the marketing of Paxlovid, the drug against covid-19 appeared first in Newsweek in Spanish.
