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SATIVEX ( sativex )

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PRODUCT MONOGRAPH NSATIVEX delta-9-tetrahydrocannabinol 27mg/mL (from Tetranabinex - Cannabis sativa L. extract) and cannabidiol 25mg/mL (from Nabidiolex - Cannabis sativa L. extract) Buccal spray Cannabinoid Analgesic Standard marketing authorization: SATIVEX® is useful as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy. Marketing authorization with conditions: SATIVEX® may be useful as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis. Marketing authorization with conditions: SATIVEX® may be useful as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. Marketing authorisations with conditions reflect the promising nature of the clinical evidence and the need for confirmatory studies to verify the clinical benefit. Patients should be advised of the conditional nature of the authorizations with conditions. GW Pharma Ltd. Histon, Cambridge UK, CB24 9BZ Control No: 149598 Distributed in Canada by: Bayer Inc., Mississauga, Ontario L4W 5R6 Date of Revision: March 31 2015 Page 1 of 55



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