The National Health Surveillance Agency (Anvisa) authorized, this Thursday (12), two new medicinal products based on Cannabis, the extracts of Cannabis sativa Mantecorp Farmasa in two dosages: 160.32 mg/mL and 79.14 mg /ml On Monday (9), the agency authorized the use of Cannabis sativa Greencare extract (160.32 mg/mL).
According to Anvisa, the three products will be manufactured in Colombia and marketed in Brazil in the form of a solution in drops for oral use.
So far, the agency has authorized 18 medicinal products based on Cannabis in Brazil, eight of which are based on extracts of Cannabis sativa and ten of the phytopharmaceutical cannabidiol.
TCH content above 0.2%
Mantecorp Farmasa Cannabis sativa extract 160.32 mg/mL and Greencare Cannabis sativa extract (160.32 mg/mL) products are the first to be approved by Anvisa with a Tetrahydrocannabinol (THC) content above 0.2% . These two products have 96 mg/mL of cannabidiol (CBD) and 0.24% THC.
According to Anvisa, the approval is based on a 2019 internal resolution which establishes that Cannabis products may contain THC content above 0.2%, as long as they are intended for palliative care exclusively for patients without therapeutic alternatives and in irreversible or terminal clinical situations.
The dispensing of Cannabis products with a THC concentration above 0.2% is carried out by the pharmacist, in pharmacies and drugstores, from the medical prescription accompanied by the presentation of a special type A prescription (yellow).
Source: CNN Brasil
