Epidyolex is a purified CBD (cannabidiol) oral solution and the only CBD medicine registered in Australia. It is approved as an add-on treatment for seizures in two rare, severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients aged 2 and over.12
How is it different from other CBD oils?
It has been assessed. Registered means the Therapeutic Goods Administration (TGA) has checked the medicine for safety, quality and effectiveness for a stated use. More than 99% of medicinal cannabis products prescribed in Australia are unapproved and have not been through that step.3 The TGA registered Epidyolex in September 2020.1
| Epidyolex | |
|---|---|
| Form | Oral solution, 100 mg/mL, 100 mL bottle |
| Approved use | Add-on treatment of seizures in Lennox-Gastaut syndrome or Dravet syndrome, age 2 and over |
| Schedule | 4 (prescription only) |
| On the PBS | Yes, for both approved uses |
Sources: TGA assessment report and PBS documents.12 “Add-on” means it is used with other anti-seizure medicines, not in place of them.
What doses are used?
Doses are set by body weight. The product label for these two syndromes goes up to 20 mg per kilogram a day, far above the 150 mg a day limit of the pharmacist-only category.45 At these doses the label reports raised liver enzymes (more than three times the upper limit of normal) in 13% of patients against 1% on placebo, with higher rates in people also taking valproate.4 Treatment is specialist-led. The dose is set by the prescriber.
What does it cost?
The published dispensed price is $1,532.91 per 100 mL bottle.6 A patient who qualifies under the PBS pays only the co-payment, which as at 1 July 2026 was $25.00 for general patients and $7.70 for concession card holders.7
Is it approved for anything else?
Not that we could confirm. A submission to subsidise it for seizures in tuberous sclerosis complex was on the November 2026 PBAC agenda, with the outcome not yet known. We could not confirm whether the TGA has added that condition to the Australian indication.8
Does its approval mean other CBD oils work for epilepsy?
No. The trial evidence is for this purified product at prescription doses, in specific syndromes. See CBD for epilepsy.
Read the full guide: Epidyolex and Sativex.
Footnotes
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Therapeutic Goods Administration. Australian public assessment report for cannabidiol, January 2021. https://www.tga.gov.au/sites/default/files/auspar-cannabidiol-210115.pdf ↩ ↩2 ↩3
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Pharmaceutical Benefits Advisory Committee. Cannabidiol public summary document, March 2026. https://www.pbs.gov.au/industry/pbac/psd/2026/03/cannabidiol-psd-march-2026-a1155.pdf?variant=3 ↩ ↩2
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Therapeutic Goods Administration. Consultation paper: reviewing the safety and regulatory oversight of unapproved medicinal cannabis products, August 2025. https://consultations.tga.gov.au/medicines-regulation-division/test-soms/user_uploads/final---consultation-paper---medicinal-cannabis-review---august-2025.pdf ↩
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US National Library of Medicine, DailyMed. Epidiolex (cannabidiol) oral solution, prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bf27097-4870-43fb-94f0-f3d0871d1eec ↩ ↩2
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Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩
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Pharmaceutical Benefits Scheme. Cannabidiol, item 12467E. https://www.pbs.gov.au/medicine/item/12467E ↩
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Pharmaceutical Benefits Scheme. Fees, patient contributions and safety net thresholds. https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee ↩
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Pharmaceutical Benefits Scheme. Medicine status: cannabidiol for tuberous sclerosis complex. https://www.pbs.gov.au/medicinestatus/document/1675.html ↩
This page is general information, not medical or legal advice. Laws and evidence change; we show the date we last checked the facts at the top of every page. Talk to your doctor or pharmacist before starting, stopping or changing any medicine.
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