Brasília – The National Health Surveillance Agency (Anvisa) has included omeprazole 20 mg (hard capsules or delayed-release) in the “Medicamentos Isentos de Prescrição (MIP)” category — medicines exempt from prescription — under Instruction Normative No. 404/2025. The change means that omeprazole at this dose and presentation can now be sold without a doctor’s prescription, specifically for relief of frequent symptoms of heartburn and acid regurgitation occurring two times or more per week.

This decision follows a regulatory evaluation that found the drug’s safety and effectiveness profile appropriate for self-use under defined conditions (max 14 days’ use, with label warnings and pharmacist guidance). Market data show that omeprazole is one of the most dispensed medications in Brazil, making this reclassification significant for pharmacies, manufacturers and public health management.
Panorama Farmacêutico

Source: Panorama Farmacêutico