Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-8053 |
| Trade Name | Dose Form | Strength | Identifier |
| Sativex | Oral spray | . | |
| Sponsor | Application date | Registration situation | Classification |
| Chiesi New Zealand Limited t/a Emerge Health BELLINGHAM WALLACE LTD SUITE 1, 470 PARNELL ROAD PARNELL AUCKLAND 1052 | 7/1/2008 | Consent given Approval date: 28/10/2010 | Class B1 Controlled Drug |
Composition
| Component | Ingredient | Manufacturer |
| oral spray | Active | |
| Cannabidiol 25 mg/mL equivalent to Cannabis sativa extract 35 mg-42 mg | GW Pharma Ltd Kent Science Park Sittingbourne Kent ME9 8AG UNITED KINGDOM | |
| Tetrahydrocannabinol 27 mg/mL equivalent to Cannabis sativa extract 38 mg-44 mg | GW Pharma Ltd Kent Science Park Sittingbourne Kent ME9 8AG UNITED KINGDOM | |
| Excipient | ||
| Ethanol | ||
| Peppermint oil | ||
| Propylene glycol |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | GW Pharma Ltd Kent Science Park Sittingbourne Kent ME9 8AG UNITED KINGDOM |
| Manufacture of Final Dose Form | GW Pharma Ltd Kent Science Park Sittingbourne Kent ME9 8AG UNITED KINGDOM |
| Packing | GW Pharma Ltd Kent Science Park Sittingbourne Kent ME9 8AG UNITED KINGDOM |
| NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
| Package | Contents | Shelf Life |
| Spray bottle, glass, metered, Glass vial w. metered pump 1 x 10mL | 90 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C |
| Spray bottle, glass, metered, Glass vial w. metered pump 3 x10mL | 270 dose units | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 6 weeks opened stored at or below 25°C |
Indications
Sativex is indicated as add-on treatment, for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) 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.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 6/3/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 14/3/2023 | |
| 7/1/2008 | New Higher-risk Medicine Application | New medicine - provisional consent | Granted 28/10/2010 | 7/1/2008 | Y |
