Cannabis: Anvisa approves first drug with THC content above 0.2%

The National Health Surveillance Agency (Anvisa) approved the use and marketing in Brazil of the first product derived from medical cannabis with a THC concentration above 0.2%. This is GreenCare Cannabis sativa Extract (160.32 mg/ml). This is the 16th cannabis-based product approved by Anvisa.

The authorization was published in the Official Gazette (DOU) this Monday (9/5). The herbal medicine will be offered in the form of a solution, with 20 mg/ml of cannabidiol (CBD) and about 0.2% of tetrahydrocannabinol (THC).

Until then, Anvisa only approved the sale of products with residual THC (up to 0.2%). The new regulation authorizes an active marker, with its intended function.

“The difference in concentrations is important, as it enables differentiated therapeutic alternatives for care, considering the diversity of indications and patient profiles”, explains the company’s CEO, Martim Prado Mattos.

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According to GreenCare’s head of marketing, Andrea Chulam, the main beneficiaries will be patients with conditions that cause chronic pain, such as fibromyalgia; cancer pain; and neurocognitive disorders such as dementia and Alzheimer’s. The compound is also indicated to stimulate the appetite of people with cancer and HIV.

“These are diseases that are urgent and cannot wait. When you have a first formulation of this on the market, with access, you can treat more pathologies”, says Chulam.

GreenCare expects the product made in Colombia to arrive in Brazil within six months. Anvisa considers that the use should be indicated by the doctor who attends the patient, with individual assessment of each case.

See the list of cannabis-based products approved by Anvisa:

  • Cannabidiol Active Pharmaceutical (20 mg/ml);
  • Cannabidiol Prati-Donaduzzi (20 mg/ml; 50 mg/ml and 200 mg/ml);
  • NuNature Cannabidiol (17.18 mg/ml);
  • NuNature Cannabidiol (34.36 mg/ml);
  • Cannabidiol Farmanguinhos (200 mg/ml);
  • Cannabidiol Verdemed (50 mg/ml);
  • Cannabidiol Belcher (150 mg/ml);
  • Cannabidiol Aura Pharma (50 mg/ml);
  • Cannabidiol Greencare (23.75 mg/ml);
  • Cannabidiol Verdemed (23.75 mg/ml);
  • Cannabis sativa Promediol extract (200 mg/ml);
  • Cannabis sativa extract Zion Medpharma (200 mg/ml);
  • Cannabis sativa Alafiamed extract (200 mg/ml);
  • Cannabis sativa Greencare extract (79.14 mg/ml);
  • Cannabis sativa Greencare extract (160.32 mg/ml) and
  • Ease Labs Cannabis sativa extract (79.14 mg/ml).

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