Australia - English - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - nabiximols, quantity: 80 mg/ml - spray, solution - excipient ingredients: propylene glycol; peppermint oil; ethanol absolute - sativex is indicated as 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - cannabidiol 25 mg/ml equivalent to cannabis sativa extract 35 mg-42 mg; tetrahydrocannabinol 27 mg/ml equivalent to cannabis sativa extract 38 mg-44 mg - oral spray - active: cannabidiol 25 mg/ml equivalent to cannabis sativa extract 35 mg-42 mg tetrahydrocannabinol 27 mg/ml equivalent to cannabis sativa extract 38 mg-44 mg excipient: ethanol peppermint oil propylene glycol - 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.

Israel - English - Ministry of Health

neopharm scientific ltd - cannabidiol drug substance ( cbd bds ); delta-9-tetrahydrocannabinol drug substance ( thc bds ) - oromucosal spray - cannabidiol drug substance ( cbd bds ) 25 mg / 1 ml; delta-9-tetrahydrocannabinol drug substance ( thc bds ) 27 mg / 1 ml - nabiximols - sativex is indicated, as add-on treatment, for symptom relief in patients with moderate to severe spasticity due to multiple sclerosis (ms) who have not responded adequately to other medication and who demonstrate at least 20 % improvement in spasticity related symptoms during a four week trial of therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

gw pharma ltd - cannabidiol; dronabinol - spray - 2.5mg/1dose ; 2.7mg/1dose

Ireland - English - HPRA (Health Products Regulatory Authority)

gw pharma ltd - cannabidiol botanical drug substance (cbd bds); delta-9-tetrahydrocannabinol botanical drug substance (thc bds) - oromucosal spray - 27 + 25 milligram(s)/millilitre - other analgesics and antipyretics; cannabinoids

Ireland - English - HPRA (Health Products Regulatory Authority)

gw pharma (international) b.v. - delta-9-tetrahydrocannabinol botanical drug substance (thc bds); cannabidiol botanical drug substance (cbd bds) - oromucosal spray, solution - 27 mg/ml + 25 milligram(s)/millilitre - other analgesics and antipyretics; cannabinoids

Ireland - English - HPRA (Health Products Regulatory Authority)

jazz pharmaceuticals ireland limited - delta-9-tetrahydrocannabinol botanical drug substance (thc bds); cannabidiol botanical drug substance (cbd bds) - oromucosal spray, solution - other analgesics and antipyretics; cannabinoids

Canada - English - Health Canada

gw pharma limited - delta-9-tetrahydrocannabinol (cannabis sativa extract); cannabidiol (cannabis sativa extract) - spray - 2.7mg; 2.5mg - delta-9-tetrahydrocannabinol (cannabis sativa extract) 2.7mg; cannabidiol (cannabis sativa extract) 2.5mg - miscellaneous therapeutic agents