The National Health Surveillance Agency (Anvisa) approved the tenth drug in the country based on Cannabis, this Tuesday (18).
Cannabis Sativa Ease Labs Extract 79.14 mg/ml is obtained from the plant extract of Cannabis Sativa, plant known as ‘marijuana’.
Anvisa says that the drug, manufactured in Colombia, will be imported and distributed in Brazil as a finished and ready-to-use product.
The body informs that the measure was published in the Official Gazette (DOU), through Resolution RE 136, of January 17, 2022.
According to the agency, the drug will be available in the form of a solution in drops for oral use, containing 47.5 mg/ml of cannabidiol (CBD) and no more than 0.2% of tetrahydrocannabinol (THC) – substances from the plant.
The drug will be marketed in pharmacies and drugstores based on medical advice through a type B prescription (blue color) — especially for prescription of psychotropic drugs, says Anvisa.
With this, so far, the country has 11 products approved by Anvisa in this category, according to Resolution of the Collegiate Board of Directors (RDC) 327/2019.
The regulatory agency reiterates that, of these 11 products, five are based on cannabis sativa and six of cannabidiol. Check the list:
- Canabidiol Prati-Donaduzzi (20 mg/mL; 50 mg/mL e 200 mg/mL);
- Canabidiol NuNature (17,18 mg/mL);
- Canabidiol NuNature (34,36 mg/mL);
- Cannabidiol Farmanguinhos (200 mg/ml);
- Canabidiol Verdemed (50 mg/mL);
- Cannabis sativa Promediol extract (200 mg/mL);
- Cannabis sativa extract Zion Medpharma (200 mg/mL);
- Canabidiol Verdemed (23,75 mg/mL);
- Cannabis sativa Alafiamed extract (200 mg/mL);
- Cannabis sativa Greencare extract (79.14 mg/mL); and
- Ease Labs Cannabis sativa extract (79.14 mg/mL).
Reference: CNN Brasil
