Anvisa authorizes new concentration of cannabidiol from a company in Minas Gerais

The National Health Surveillance Agency (Anvisa) published on this Monday (8) Resolution-RE No. 4,944 in the Official Gazette of the Union (DOU), granting the inclusion of a new concentration for the Cannabis-based product from Ease Labs Laboratório Farmacêutico Ltda. The measure authorizes the commercialization of isolated cannabidiol at a dosage of 300 mg/ml.

According to the document, signed by the General Manager of Medicines of the agency, Raphael Sanches Pereira, the approval covers two specific presentations for the oral solution: bottles of 10 ml and 30 ml, both accompanied by droppers.

The resolution establishes that the product's validity is 18 months. The sanitary authorization linked to the process (No. 25351.520419/2022-48) is due to expire in November 2027.

The publication formalizes the approval of the petition for the "inclusion of a new concentration" in an existing registration of the pharmaceutical company, allowing the expansion of dosage options available in the regulated market for this specific product.

“It is the first product in the country at this concentration, providing a more advantageous cost per milligram of CBD. With a larger quantity in a single bottle and better cost-effectiveness, we expand access and reduce the risk of underdosing — a recurring problem that often limits the evolution of treatments,” says Gustavo Palhares, co-CEO of Ease Labs.