Cannabinoid | Moderate Risk

Nabiximols (THC:CBD Oromucosal Spray) (Sativex)

What to know about Nabiximols (THC:CBD Oromucosal Spray) — also sold as Sativex: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.

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

Risk Level Moderate
Risk Points 5
CNS Depressant No
Respiratory Risk No

TGA registered for MS spasticity

How Nabiximols (THC:CBD Oromucosal Spray) is regulated

Nabiximols (THC:CBD Oromucosal Spray) is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.

Australia TGA / PBS / State Schemes

Classified as S8 under the Therapeutic Goods Administration (TGA).

Clinical Evidence

  • MHRA Approval: Sativex for MS Spasticity (UK) - MHRA (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) - TGA (2013)

    Sativex (nabiximols) is TGA-registered for MS spasticity. THC:CBD 1:1 oromucosal spray. S8.

    Full TGA registration

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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.