Canada - English - Health Canada

bristol-myers squibb canada - ozanimod (ozanimod hydrochloride); ozanimod (ozanimod hydrochloride) - capsule - 0.23mg; 0.46mg - ozanimod (ozanimod hydrochloride) 0.23mg; ozanimod (ozanimod hydrochloride) 0.46mg - immunomodulatory agents

United States - English - NLM (National Library of Medicine)

celgene corporation - ozanimod hydrochloride (unii: 3upr33jaam) (ozanimod - unii:z80293urpv) - zeposia is indicated for the treatment of: zeposia is contraindicated in patients who: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to zeposia during pregnancy. healthcare providers are encouraged to register patients on-line, or pregnant women may register themselves at https://www.zeposiapregnancyregistry.com/or by calling 1-877-301-9314. currently this registry is enrolling women with ms. information regarding registration of pregnant women with uc will be made available in the future. risk summary there are no adequate data on the developmental risk associated with the use of zeposia in pregnant women. in animal studies, administration of ozanimod during pregnancy produced adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity. in rabbits, fetal blood vessel malformations occurred at clinically relevant maternal ozanimod and metab

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.23 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.46 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - ozanimod as hydrochloride - capsules - ozanimod as hydrochloride 0.92 mg - ozanimod - zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.zeposia is indicated for the treatment of moderately to severely active ulcerative colitis (uc) in adults.

Canada - English - Health Canada

bristol-myers squibb canada - ozanimod (ozanimod hydrochloride) - capsule - 0.92mg - ozanimod (ozanimod hydrochloride) 0.92mg - immunomodulatory agents

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

celgene pty ltd - ozanimod hydrochloride, quantity: 500 microgram (equivalent: ozanimod, qty 460 microgram) - capsule - excipient ingredients: gelatin; croscarmellose sodium; iron oxide black; magnesium stearate; microcrystalline cellulose; iron oxide red; iron oxide yellow; titanium dioxide; silicon dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide; ethanol absolute; ammonia - multiple sclerosis zeposia is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.,ulcerative colitis zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

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

celgene pty ltd - ozanimod hydrochloride, quantity: 1 mg (equivalent: ozanimod, qty 0.92 mg) - capsule - excipient ingredients: iron oxide red; gelatin; silicon dioxide; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; magnesium stearate; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute; ammonia - multiple sclerosis zeposia is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.,ulcerative colitis zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ozanimod hydrochloride - multiple sclerosis, relapsing-remitting; colitis, ulcerative - immunosuppressants - multiple sclerosiszeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (rrms) with active disease as defined by clinical or imaging features.ulcerative colitiszeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Singapore - English - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - ozanimod hydrochloride eqv. ozanimod - capsule - ozanimod hydrochloride eqv. ozanimod 0.92 mg