Unió Europea - anglès - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride  - multiple sclerosis, relapsing-remitting - immunosuppressants - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1)orpatients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Unió Europea - anglès - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride  - multiple sclerosis, relapsing-remitting - immunosuppressants - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.,

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

neuraxpharm ireland limited - fingolimod - capsule, hard - 0.5 milligram(s) - fingolimod

Jordània - anglès - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة مستودع الأدوية الأردني - the jordan drugstore co - fingolimod 0.5 mg - 0.5 mg

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

bluefish pharmaceuticals ab - fingolimod hydrochloride - capsule, hard - fingolimod

Estats Units - anglès - 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

Irlanda - anglès - HPRA (Health Products Regulatory Authority)

msn labs europe limited - fingolimod - capsule, hard - fingolimod

Singapur - anglès - HSA (Health Sciences Authority)

accord healthcare private limited - fingolimod hydrochloride eqv. fingolimod - capsule, gelatin coated - fingolimod hydrochloride eqv. fingolimod 0.5 mg

República de Sud-àfrica - anglès - South African Health Products Regulatory Authority (SAHPRA)

adcock ingram limited - capsules - see ingredients - each capsule contains fingolimod 0,5 mg

Estats Units - anglès - 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