Brazil’s regulator Anvisa analyzes antiviral drug to treat monkeypox
Brazil’s national drug regulator Anvisa has received from the Ministry of Health a request for analysis of Tecovirimat, a drug produced by SIGA Technologies company, to treat patients at risk of developing severe forms of monkeypox.
Anvisa informed today (Aug. 24), that all efforts will be made to carry out the evaluation and decision processes. The deadline for the analysis is seven working days.
The final decision will be deliberated by the Regulator's Collegiate Board of Directors, after the Monkeypox Emergency Technical Commission analyzes the essential characteristics of the drug, and check if they are the same approved by foreign regulatory authorities, equivalent to Anvisa, such as the manufacturer, concentration, pharmaceutical form, therapeutic indications, contraindications, posology, target population, route of administration of the medicine, and method of use, among other information.
