Nabiximols (THC:CBD Oromucosal Spray) (Sativex)
Nabiximols (THC:CBD Oromucosal Spray) risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Sativex.
Nabiximols (THC:CBD Oromucosal Spray) (brand names: Sativex) is classified as Moderate risk (5 risk points) by AllMeds. It is a S8 medication under the TGA in Australia. TGA registered for MS spasticity
Key Takeaways
- TGA Schedule: S8 in Australia
- Risk level: Moderate (5 points)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S8 | Not PBS listed |
Risk Profile
TGA registered for MS spasticity
Regulatory and Compliance Guidance
When Nabiximols (THC:CBD Oromucosal Spray) 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 S8 under the Therapeutic Goods Administration (TGA).
Clinical Evidence
- MHRA Approval: Sativex for MS Spasticity (UK) (2010)
First cannabis-based medicine approved in the UK. Licensed for MS spasticity not adequately responding to other medications.
UK regulatory approval
- ARTG Registration: Sativex (nabiximols) (2013)
Sativex (nabiximols) is TGA-registered for MS spasticity. THC:CBD 1:1 oromucosal spray. S8.
Full TGA registration
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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.