Cannabidiol (Epidyolex) (Epidyolex)
Cannabidiol (Epidyolex) risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Epidyolex.
Cannabidiol (Epidyolex) (brand names: Epidyolex) is classified as Moderate risk (5 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. TGA registered for Dravet/Lennox-Gastaut syndrome
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Moderate (5 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | Not PBS listed |
Risk Profile
TGA registered for Dravet/Lennox-Gastaut syndrome
Regulatory and Compliance Guidance
When Cannabidiol (Epidyolex) appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Clinical Evidence
- FDA Approval of Epidiolex (cannabidiol) (2018)
First cannabis-derived drug approved by FDA. For Dravet and Lennox-Gastaut syndrome. Phase 3 RCTs demonstrated efficacy.
FDA approval with full clinical trial data
- ARTG Registration: Epidyolex (cannabidiol) — ARTG 340262 (2021)
Epidyolex is TGA-registered (ARTG) for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years and older.
Full TGA registration — highest Australian regulatory bar
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.