Revised: 29 June 2020
Medicines
Sativex® Oromucosal Spray
What is Sativex®?
What is Sativex?
What is Sativex approved for?
All New Zealand-registered
medical practitioners can prescribe Sativex
What is Sativex?
Sativex is a cannabis-based product. It is 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. Each spray administers 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?
Sativex is an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS). It is approved for MS patients 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.
- The New Zealand Sativex data sheet (PDF 125 KB, 14 pages)
All New Zealand-registered medical practitioners can prescribe Sativex
With the publication of the gazette notice on 4 March 2020, all medical practitioners registered with the Medical Council of New Zealand can now prescribe Sativex for any indication. This includes vocationally-registered general practitioners, who are no longer required to apply for Ministerial approval to prescribe.
Medicinal Cannabis Agency
The Ministry of Health website has information about the Medicinal Cannabis Agency and the Medicinal Cannabis Scheme. You’ll find information for industry (including guidelines and forms), health professionals and consumers. You can also subscribe to receive updates from the Agency.
