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Medicines

Revised: 1 December 2016

Sativex® Oromucosal Spray

What is Sativex®?

Sativex® is a cannabis-based product classified as a Schedule 2, Part 1 (Class B1) controlled drug product under the Misuse of Drugs Act 1975. Sativex® is an oromucosal (mouth) spray administering a metered, actuated dose containing the cannabis extracts delta-9-tetrahydrocannabinol (THC) (2.7 mg/spray) and cannabidiol (CBD) (2.5 mg/spray).

What is Sativex® approved for?

In New Zealand Sativex® is approved for use as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to Multiple Sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

Any other use of Sativex® is an unapproved use of this medicine in New Zealand.

Prescribers should be aware that the clinical safety and efficacy has not been fully investigated in other medical conditions and the long-term usefulness of this medicine has not been established.

Irrespective of whether prescribing is for an approved or unapproved use, extended periods of treatment should be periodically re-evaluated to examine the long-term safety and efficacy of the medicine for the individual patient.

Ministerial approval required before prescribing

Ministerial approval is required before Sativex® can be prescribed by a New Zealand registered medical practitioner under regulation 22 of the Misuse of Drugs Regulations 1977. The requirement for Ministerial approval for Sativex® was delegated to the Ministry of Health some years ago.

Ministerial approval has been granted to enable the prescribing of Sativex® as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (approved use), without the requirement for an application for approval to prescribe to be made. Please refer to the attached information for prescribers, and the published approval notice for details.

To apply for Ministerial approval to prescribe Sativex® for an unapproved use for a specified patient, practitioners must complete the following application form:

Application process

All applications and correspondence should be sent to:

Sativex Applications
Medicines Control
Ministry of Health
PO Box 5013
WELLINGTON 6011

Information for prescribers, pharmacies and patients

Information on the prescribing of cannabis-based products is available on the Ministry of Health website (www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/prescribing-cannabis-based-products).

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