Israel - engelsk - 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.

Irland - engelsk - 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

Irland - engelsk - 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

Israel - hebraisk - Ministry of Health

neopharm scientific ltd - cannabidiol drug substance ( cbd bds ); delta-9-tetrahydrocannabinol drug substance ( thc bds ) - ספריי לחלל הפה - 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.sativex is indicated as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis in adults.

Irland - engelsk - 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

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Canada - engelsk - 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

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

tilray portugal unipessoal, lda. - delta-9-tetrahidrocanabinol (thc pfv) + canabidiol (cbd pfv), prep de fármacos vegetais, ext cannabis sativa - solução oral - 5 mg/ml + 20 mg/ml - delta-9-tetrahidrocanabinol 6.7 mg/ml ; canabidiol 28.6 mg/ml - n/a - preparações da canábis - duração do tratamento: longa duração

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

chiesi australia pty ltd - cannabidiol, quantity: 100 mg/ml - oral liquid, solution - excipient ingredients: sesame oil; sucralose; ethanol absolute; flavour - epidyolex is indicated for use as adjunctive therapy of seizures associated with lennox-gastaut syndrome (lgs) or dravet syndrome (ds) for patients 2 years of age and older.

Israel - engelsk - Ministry of Health

neopharm ltd, israel - cannabidiol - solution - cannabidiol 100 mg / 1 ml - cannabidiol - epidiolex is indicated for use as adjunctive therapy of seizures associated with lennox-gastaut syndrome (lgs), dravet syndrome (ds), or tuberous sclerosis complex (tsc) in patients 1 year of age and older.