QCOSTARICA – The Ministry of Health notified Merck Sharp & Dohme on Wednesday of the emergency use authorization for the Molnupiravir 200 mg capsules, which enables the company to sell it in Costa Rica.
Molnupiravir is an oral, small-molecule antiviral prodrug that is active against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for the treatment of mild to moderate COVID-19 disease in adults with positive direct viral test results and who are at high risk of progression to severe COVID-19, including hospitalizations or death.
The New England Journal of Medicine concluded that early treatment with Molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19.
Molnupiravir dose in adult patients is 800 mg (four 200 mg capsules) to be administered orally every 12 hours for 5 days, with or without food, and should be taken as soon as possible after a diagnosis of the Covid-19 infection.
The use authorization is provided based on the Administrative Resolution MS-DM-RM-1363-2022 published on January 24 of this year, which establishes the requirements to obtain an Authorization for the Use and Import of medicines to treat Covid-19. 19, based on the recognition of the Marketing Authorization or Emergency Use Authorization of Strict Regulatory Authorities or of medicines recommended by the World Health Organization.
As part of the authorization, Merck Sharp & Dohme must maintain records of the distribution of the medicine (ie, lot numbers, quantity, date and destination), as well as submit monthly reports of possible adverse or safety events.
When the medication will be on sale in Costa Rica or its cost is not yet known.