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Epidyolex and Sativex: the registered cannabis medicines

Only two cannabis medicines are fully registered in Australia. What Epidyolex and Sativex are approved for, their PBS status, and what is pending.

Facts checked 13 November 20266 min readHow we research

Two cannabis medicines are fully registered in Australia: Epidyolex, which contains CBD, and Sativex, which contains both THC and CBD.1 Registered means the Therapeutic Goods Administration (TGA) has assessed the medicine for safety, quality and effectiveness for a stated use. Every other medicinal cannabis product prescribed in Australia is unapproved.2

Why does registration matter?

A registered medicine has been through the standard test for a medicine. The company behind it gave the TGA trial evidence, and the TGA approved it for a specific use, called its indication. The medicine is then entered on the Australian Register of Therapeutic Goods (ARTG).

Unapproved products have not been through that step. The TGA says they “have not been assessed by us for safety, quality or effectiveness”.2 More than 99% of medicinal cannabis products prescribed in Australia are in this group.3

The TGA told its scheduling committee on 18 March 2026: “There are only 2 medicinal cannabis medicines that have been Registered on the Australian Register of Therapeutic Goods”.1 Four medical devices for use with medicinal cannabis are also approved. None of them can be used to vape cannabis oils.3

How do the two medicines compare?

Epidyolex Sativex
Active ingredient Cannabidiol (CBD) Nabiximols (roughly equal THC and CBD)
Form Oral solution, 100 mg/mL, 100 mL bottle Spray used in the mouth
ARTG number 328860 181978
Registered September 2020 2012
Approved use Add-on treatment of seizures in Lennox-Gastaut syndrome or Dravet syndrome, age 2 and over Moderate to severe spasticity in multiple sclerosis
Schedule 4 (prescription only) 8 (controlled drug)
On the PBS Yes, for both approved uses No

Sources for the Epidyolex column are the TGA assessment report and PBS documents.45 Sources for the Sativex column are the TGA assessment report, MS Australia and the Poisons Standard.678

What is Epidyolex?

Epidyolex is a purified CBD oral solution. The TGA decided to register it on 18 September 2020 and it was entered on the ARTG on 21 September 2020.4

Its approved use is as “adjunctive therapy” for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older.5 Adjunctive means it is added to other anti-seizure medicines, not used in place of them. Both are rare, severe forms of epilepsy.

This is the only use for which a CBD medicine has been approved in Australia. The trial evidence is covered on our epilepsy page.

The doses used for epilepsy 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 for the pharmacist-only category.98 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 the anti-seizure medicine valproate.9 This is one reason treatment is specialist-led. See CBD and the liver and CBD drug interactions.

Is Epidyolex on the PBS?

Yes, for both approved uses. The Pharmaceutical Benefits Scheme (PBS) is the Commonwealth program that subsidises medicines.

Dravet syndrome. Listed under PBS item 12467E as “Authority Required”, which means the prescriber must get approval before writing the script.10 The current criteria require that seizures are not adequately controlled with at least two other anti-seizure medicines, that Epidyolex is used as an add-on, and that treatment is led by a neurologist.5

Lennox-Gastaut syndrome. The Pharmaceutical Benefits Advisory Committee (PBAC) rejected this listing in March 2022 and recommended it in September 2022. It was listed on 1 June 2023.11 It is now “Authority Required (STREAMLINED)”, a simpler process, after the PBAC recommended easing the rules in July 2025. The change dropped the requirement to have tried at least two other medicines, allowed paediatricians to start treatment and allowed GPs to continue it.1112

Cost. The published dispensed price is $1,532.91 per 100 mL bottle. A special pricing arrangement applies, so the price the government actually pays is lower.10 A patient who qualifies pays only the PBS co-payment. As at 1 July 2026 that was $25.00 for general patients and $7.70 for concession card holders. The general co-payment was cut from $31.60 on 1 January 2026.13

See PBS, Medicare and health insurance.

What is pending for Epidyolex?

As of November 2026, three matters were unresolved.

  • Dravet criteria. In March 2026 the PBAC recommended easing the Dravet rules in the same way as for Lennox-Gastaut syndrome. When we checked, the change was not yet reflected on the PBS item page.5
  • Tuberous sclerosis complex. A submission to subsidise Epidyolex for seizures in this condition was on the agenda for the November 2026 PBAC meeting. The outcome had not been published as of 13 November 2026.14 We could not confirm whether the TGA has added this condition to the approved Australian indication.
  • Bottles per script. The same meeting was to consider raising the maximum quantity from 1 bottle to 5 bottles per prescription.15

What is Sativex?

Sativex is the brand name for nabiximols, a spray used inside the mouth. It contains roughly equal amounts of THC and CBD, so it is not a CBD medicine in the sense used on this site. It was registered in 2012 for moderate to severe spasticity (muscle stiffness and spasms) in multiple sclerosis.67

Because it contains THC, Sativex is a Schedule 8 controlled drug with its own entry in the Poisons Standard.8 THC can impair driving and is what roadside tests detect. See CBD and driving and CBD vs THC.

Sativex is not on the PBS. The PBAC rejected it in July 2013 and again in March 2020.16 We found no record of a later PBAC consideration, but could not confirm that none has occurred. We could not confirm a current price. The evidence is covered on our multiple sclerosis page.

Why are there only two?

Registration needs large clinical trials for a specific product and condition. The TGA’s view is that ready access to unapproved products through special pathways “has reduced or removed the incentive” for companies to generate that evidence.3

The same applies to low-dose pharmacist-only CBD. The TGA said in August 2025 that no complete application for such a product had been submitted.3 See over-the-counter CBD.

Does registration mean these medicines suit everyone with the condition?

No. Registration covers a stated use in a stated group of patients. Whether either medicine is right for a person is a decision for their treating doctor. The PBS rules for Epidyolex, for example, still require it to be an add-on to other anti-seizure treatment.5

Footnotes

  1. Therapeutic Goods Administration. Paper to the scheduling advisory committee, 18 March 2026, released as FOI 26-2886. https://www.tga.gov.au/sites/default/files/2026-06/FOI%2026-2886.PDF ↩ ↩2

  2. Therapeutic Goods Administration. Medicinal cannabis access pathways. https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis/access-pathways ↩ ↩2

  3. 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 ↩ ↩2 ↩3 ↩4

  4. Therapeutic Goods Administration. Australian public assessment report for cannabidiol, January 2021. https://www.tga.gov.au/sites/default/files/auspar-cannabidiol-210115.pdf ↩ ↩2

  5. 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 ↩3 ↩4 ↩5

  6. Therapeutic Goods Administration. Australian public assessment report for nabiximols, 2013. https://www.tga.gov.au/sites/default/files/auspar-nabiximols-130927.pdf ↩ ↩2

  7. MS Australia. Disappointing outcomes for PBS inclusion. https://www.msaustralia.org.au/news/disappointing-outcomes-for-pbs-inclusion/ ↩ ↩2

  8. Australian Government. Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026. https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf ↩ ↩2 ↩3

  9. 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

  10. Pharmaceutical Benefits Scheme. Cannabidiol, item 12467E. https://www.pbs.gov.au/medicine/item/12467E ↩ ↩2

  11. Pharmaceutical Benefits Scheme. Medicine status: cannabidiol for Lennox-Gastaut syndrome. https://www.pbs.gov.au/medicinestatus/document/898.html ↩ ↩2

  12. Pharmaceutical Benefits Scheme. Cannabidiol, item 13277T. https://www.pbs.gov.au/medicine/item/13277T ↩

  13. Pharmaceutical Benefits Scheme. Fees, patient contributions and safety net thresholds. https://www.pbs.gov.au/info/healthpro/explanatory-notes/front/fee ↩

  14. Pharmaceutical Benefits Scheme. Medicine status: cannabidiol for tuberous sclerosis complex. https://www.pbs.gov.au/medicinestatus/document/1675.html ↩

  15. Pharmaceutical Benefits Advisory Committee. November 2026 meeting agenda. https://www.pbs.gov.au/industry/listing/elements/pbac-meetings/agenda/pdf/2026/November-2026-PBAC-Meeting-Web-Agenda-v6.pdf ↩

  16. Pharmaceutical Benefits Scheme. Medicine status: nabiximols. https://www.pbs.gov.au/medicinestatus/document/14.html ↩

Common questions

Is Epidyolex the same as CBD oil?

Epidyolex contains CBD as its active ingredient, at 100 mg per mL. The difference is regulatory. It is the only CBD medicine the TGA has assessed for safety, quality and effectiveness and registered. Other prescribed CBD oils are unapproved medicines.

Is Epidyolex on the PBS?

Yes, for seizures in Dravet syndrome and Lennox-Gastaut syndrome, under authority prescribing rules. As at 1 July 2026 the patient co-payment was $25.00, or $7.70 with a concession card.

Does Sativex contain THC?

Yes. Sativex contains roughly equal amounts of THC and CBD. It is a Schedule 8 controlled drug, and THC can be detected in roadside drug tests.

Why are only two cannabis medicines registered?

Registration needs clinical trial evidence for a specific product and use. The TGA says ready access to unapproved products through special pathways has reduced or removed the incentive for companies to generate that evidence.

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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