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.
3 Cards_Gallery_of_Photos (2)
Cannabis, also known as marijuana, is a plant of Asian origin full of controversy. Socially marginalized, in the light of science, however, it has medicinal potential to treat various pathologies.iStock
According to experts, cannabis has substances, such as cannabinoids, capable of acting and triggering reactions in various areas of the body, such as the brain.seksan Mongkhonkhamsao/ Getty Images
Cannabis has three species: ruderalis, indica and sativa, with the last two being the most popular. In the case of sativa, we can also highlight cannabidiol, which has a relaxing effect and, therefore, is used for therapeutic purposes.janiecbros/ Getty Images
In addition to cannabidiol, in cannabis satira it is possible to find tetrahydrocannabidiol, a substance capable of generating sensations of pleasure, relief, euphoria, among others.wera Rodsawang/ Getty Images
In the pharmaceutical industry, the properties of cannabis can work as an anticonvulsant, analgesic and sedative in the treatment of diseases such as: epilepsy, schizophrenia, multiple sclerosis, Parkinson’s and severe pain.janiecbros/ Getty Images
For these reasons, more and more countries have regulated the use of the substance to treat illnesses, although many still prohibit the use of cannabis for recreational purposes.Francesco Carta photographer/ Getty Images
Canada, United States, Germany, Netherlands, Denmark, Italy, Spain, Belgium, Portugal, among other European countries, allow, with their own rules, the use of marijuana for medical purposesLauriPatterson/ Getty Images
In Latin America, countries such as Argentina, Uruguay, Colombia, Jamaica, Ecuador and Mexico, for example, also release cannabis for medicinal and therapeutic purposes.David Trood/Getty Images
Each state defines the specifics around the use of medical marijuana, but in general, authorizations basically work in two ways: permission for therapeutic and medical use only or authorization for recreational use as well.Bloomberg Creative/Getty Images
In Brazil, Anvisa has allowed the importation and use of the substance in some medicines since 2014. Until then, the plants still needed to be brought from abroad. However, in 2021, the Chamber of Deputies approved bill 399/2015 that authorized the cultivation of Cannabis sativa in Brazil for medicinal, veterinary, scientific and industrial purposes.Esther Kelleter / EyeEm / Getty Images
Here, to purchase medicines or cannabis-derived products (both for medicinal purposes) you must have a medical prescription. In addition, it is necessary to be able to purchase the products, since the amount to be disbursed can reach four digitsRevolution7ion93/ Getty Images
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