Canada - English - Health Canada

teva canada limited - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

Canada - English - Health Canada

taro pharmaceuticals inc - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

Canada - English - Health Canada

mylan pharmaceuticals ulc - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

Canada - English - Health Canada

pharmascience inc - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

Canada - English - Health Canada

apotex inc - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

Canada - English - Health Canada

accord healthcare inc - fingolimod (fingolimod hydrochloride) - capsule - 0.5mg - fingolimod (fingolimod hydrochloride) 0.5mg - immunomodulatory agents

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

dr. reddy's laboratories inc - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1) ] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiatio

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

zydus pharmaceuticals usa inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiation [see warnings and prec

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

apotex corp. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (tia), decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warnings and precautions (5.1)] - a baseline qtc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with class ia or class iii anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. observed reactions include rash, urticaria and angioedema upon treatment initiation

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

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.28 mg (equivalent: fingolimod, qty 0.25 mg) - capsule, hard - excipient ingredients: mannitol; hyprolose; hydroxypropylbetadex; magnesium stearate; shellac; iron oxide black; propylene glycol; gelatin; strong ammonia solution; titanium dioxide; iron oxide yellow - fingolimod sandoz is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.