Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

yousif mahmood hussain & bahrain pharmacy co - fingolimodum - capsule - 0.5

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

sandoz pty ltd - fingolimod hydrochloride, quantity: 0.56 mg (equivalent: fingolimod, qty 0.5 mg) - capsule, hard - excipient ingredients: mannitol; iron oxide yellow; magnesium stearate; gelatin; titanium dioxide - 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.

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

biocon pharma 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 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation’s gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, 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 warning and precautions (5.1)] - a baseline qtc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with cla

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

strides pharma science limited - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsule 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 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation's gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, 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 clas

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

ascend laboratories, llc - 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 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation’s gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod capsules are contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, 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 treatm

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

glenmark pharmaceuticals inc., usa - 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: risk summary based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malformations in rats were pe

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

mylan pharmaceuticals 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: based on findings from animal studies, fingolimod capsules may cause fetal harm when administered to a pregnant woman. data from prospective reports to the fingolimod pregnancy registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malformations in rats were persis

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

solco healthcare us, llc - fingolimod (unii: 3qn8byn5qf) (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: risk summary based on findings from animal studies, fingolimod capsules may cause fetal harm when administered to a pregnant woman. data from prospective reports to the fingolimod capsules pregnancy registry (gpr) are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. in oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. in rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. the most common fetal visceral malfo

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

teva pharma australia pty ltd - fingolimod hydrochloride, quantity: 560 microgram (equivalent: fingolimod, qty 500 microgram) - capsule, hard - excipient ingredients: iron oxide yellow; titanium dioxide; gelatin; sodium lauryl sulfate; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - fingolimod-teva 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

rowa pharmaceuticals limited - fingolimod - capsule, hard - 0.5 milligram(s) - fingolimod