European Union - English - 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.

European Union - English - 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.,

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

Singapore - English - HSA (Health Sciences Authority)

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

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

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

Malta - English - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - hard capsule - fingolimod 0.5 mg - immunosuppressants