In Australia there are only two products listed on Australian Register of Therapeutic Goods (ARTG), nabiximols (Sativex) and CBD (Epidyolex).
Sativex 50:50 CBD:THC oromucosal spray (27mg THC and 25mg CBD per mL), a Schedule 4 drug, is approved for the treatment and symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Epidyolex 100mg/ml CBD oral solution in sesame oil, a Schedule 4 drug, is approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older and, has recently been listed on the Pharmaceutical Benefits Scheme (PBS).
The TGA recently approved a legal pathway for low-dose CBD formulations to be provided over the counter as Schedule 3 pharmacist-only medications for conditions that do not require medical oversight. However, no product has yet been formally approved within this pathway.
There are more than 300 unapproved medical cannabis products available in Australia via the TGA Special Access Scheme Category B or through Authorised Prescribers.
These products need to meet the Australia Standard TGO 93 to ensure they are free of contaminants; contain the compounds and concentration of compounds they claim; and that CBD products do not exceed the 2% other cannabinoid limit.
The TGA has provided a list of unapproved products available through the SAS B or Authorised Prescriber pathway listed as ‘medicinal cannabis products by active ingredient’ categorised on proportion of cannabidiol content compared with the total cannabinoid content of the medicine as listed on the product label and self-declared by the sponsors. The TGA cannot guarantee the accuracy or currency of the information or listings.
CBD medicinal cannabis product (CBD ≥98%)
CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
Balanced medicinal cannabis product (CBD< 60% and≥ 40%)
THC dominant Medicinal Cannabis Product (THC 60-98%)
THC medicinal cannabis product (THC >98%)
Made in Australia, Xativa™ is formulated using WaferiX™, which is patented sublingual delivery technology. Each wafer contains a nano-emulsion of highly bioavailable broad-spectrum cannabis extract and 30+ terpenes and other beneficial molecules naturally occurring in cannabis.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Developed specifically for optimum bioavailability and consistency, Satipharm Gelpell® capsules are a clinically proven way to take CBD. Satipharm CBD capsules are also gastro-resistant, with no additives or preservatives present, ensuring release of CBD directly into the small intestine.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Ananda Hemp manufactures high-quality and affordable full and THC free broad spectrum hemp extracts. Ananda Hemp’s CBD dominant products are available in varying formats including oils, soft gels and creams.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Australian grown and made, full spectrum whole flower medical cannabis, ANTG conforms to stringent Australian and EU pharmaceutical standards to ensure quality control at every step of the process.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Locally formulated in Australia, in compliance with AU-GMP pharmaceutical quality standards, the Adaya range of medicinal cannabis products includes a portfolio of C02 extracted oral THC:CBD formulations in Medium-Chain Triglyceride oil and Australian cultivated whole flower products rich in therapeutic phytocannabinoids and terpenoids.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Produced under AU GMP for consistent, pharmaceutical grade quality medications, Medigrowth’s products are independently lab tested for quality assurance. The product range includes a versatile suite of CBD and THC whole-plant extract medicinal cannabis oils made in Australia.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Heyday, 100% Australian owned and grown medical cannabis flower, grown in an outdoor GMP facility in rural Victoria using regenerative agriculture and organic farming practices.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Formulated from proprietary strains of cannabis, with organic, pharmaceutical grade olive oil, Cann Pharmaceutical Australia (CPA) offers high quality, whole-plant medicinal cannabis oils for sublingual administration. The strains are grown using organic, pesticide free techniques, which have been refined by better™ for over 10 years. Manufactured in compliance with the strictest GMP requirements.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
An Australian sports science company focused on researching, developing, and commercialising a range of Medicinal Cannabis products initially for the treatment of pain, mental health disorders and sport-related ailments.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Tilray is the first GMP-certified purified and full-spectrum medical cannabis producer supplying cannabis extract products to government and hospital clients as well as to leading pharmacies across Australia.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
MediCann Health is an Australian company offering Australian grown and made, science backed, reliable and affordable cannabis medicines to patients. Maali is a line of premium Australian medicinal cannabis medicines including flower and oils.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Established across four continents, including Australia, MGC is a biopharma company with a “Nature to Medicine” strategy at the forefront of the emerging phytocannabinoid and plant derived medicine markets. Our mission is to build an innovative, global bio-pharma company providing standardised, affordable plant derived medicines of the highest regulatory compliance. Our range of affordable plant derived medicines meet the highest regulatory compliance requirements.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Humacology is an Australian company that believes in the incredible power of medicinal cannabis. Our doctors craft affordable, high-potency CBD, CBN and CBG oils, all with proprietary blends of terpenes to maximise their efficacy.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Inspired from our work in research, clinical trials and partnerships and applying evidence based scientific rigour we are harnessing the unique extracts and compounds from cloned cannabis plants, grown under Good Agriculture Practices, harvested and extracted under EU GMP processes, and have meticulously formulated BOD’s medical cannabis products.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Entoura is an Australian owned and operated healthcare company, developing and supplying high quality medicinal cannabis products, training and education.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
A global biopharmaceutical company believing in ethical medicine and committed to world class science and clinical trials. Doctors and patients should have the same confidence in clinically validated cannabinoid-based medicines that they would in any other prescription pharmaceuticals.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
Originally Medifarm, early contenders in seeking and gaining Australian licensing for medicinal cannabis cultivation, manufacturing and research they partnered with Tikun Olam, a global company with more than 15 year and 30,000 patients experience, Medifarm transitioned to Tikun Australia whilst remaining 100% Australian.
N.B. These products are not registered on the Australian Register of Therapeutic Goods (ARTG) and are only available to be prescribed through the TGA’s Special Access Scheme (SAS), the Authorised Prescriber Scheme (AP) or by clinical trial.
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