Brazil grants registration for first cannabis-based drug

The Brazilian Health Surveillance Agency (ANVISA) granted the registration for the first cannabis-based (marijuana) medicine in Brazil. Dubbed Mevatyl, the product is prescribed for the treatment of adults who suffer from spasms triggered by multiple sclerosis. ANVISA registration is a document required to sell any drug in Brazil.

The rules for registering marijuana drugs were approved by ANVISA in November 2016. Known as Sativex out of Brazil, Mevatyl has been approved in 28 countries, including the United States, Canada, Germany, and Denmark.

According to clinical data studies, users will very unlikely have an addiction to the medicine. The product will be sold with a black strip on the box indicating that its use will require medical prescription and an Informed Consent Form.

The medicine is produced by the British company GW Pharma Limited, and the Beaufour Ipsen Farmacêutica Ltda. (based in São Paulo) obtained the drug registration in Brazil.

Translated by Amarílis Anchieta