Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-8053
Trade NameDose FormStrengthIdentifier
SativexOral spray.
SponsorApplication dateRegistration situationClassification
Chiesi New Zealand Limited t/a Emerge Health
BELLINGHAM WALLACE LTD
SUITE 1, 470 PARNELL ROAD
PARNELL
AUCKLAND 1052
7/1/2008Consent given
Approval date: 19/11/2010
Class B1 Controlled Drug
 

Composition

ComponentIngredientManufacturer
oral sprayActive 
 Cannabidiol 25 mg/mL equivalent to Cannabis sativa extract 35 mg-42 mgGW Pharma Ltd
Kent Science Park
Sittingbourne
Kent ME9 8AG
United Kingdom
 Tetrahydrocannabinol 27 mg/mL equivalent to Cannabis sativa extract 38 mg-44 mgGW Pharma Ltd
Kent Science Park
Sittingbourne
Kent ME9 8AG
United Kingdom
 Excipient 
 Ethanol
 Peppermint oil
 Propylene glycol

Production

Manufacturing stepManufacturer
Finished Product TestingGW Pharma Ltd
Kent Science Park
Sittingbourne
Kent ME9 8AG
United Kingdom
Manufacture of Final Dose FormGW Pharma Ltd
Kent Science Park
Sittingbourne
Kent ME9 8AG
United Kingdom
PackingDHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022
 GW Pharma Ltd
Kent Science Park
Sittingbourne
Kent ME9 8AG
United Kingdom
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Spray bottle, glass, metered, Glass vial w. metered pump 1 x 5.5mL48 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 1 x 10mL90 dose units24 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 2 x 5.5mL96 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 3 x 5.5mL144 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 2 x 10mL180 dose units24 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 4 x 5.5mL192 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 5 x 5.5mL240 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 3 x10mL270 dose units24 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 6 x 5.5mL288 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 4 x 10mL360 dose units24 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 5 x 10mL450 dose units24 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 10 x 5.5mL480 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 6 x 10mL540 dose units24 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 12 x 5.5mL576 dose units24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
4 weeks opened stored at or below 25°C
Spray bottle, glass, metered, Glass vial w. metered pump 10 x 10mL900 dose units24 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 12 x 10mL1080 dose units24 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 DateApplication TypeChange(s)StatusPayment DatePriority
5/5/2021Self-Assessable Change NotificationLabelling - Grade 1 (Self assessable); Data sheet - miscellaneous changes (Self assessable)Notified13/5/2021 
7/1/2008New Higher-risk Medicine ApplicationNew medicine - provisional consentGranted 28/10/20107/1/2008Y
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