Európska únia - slovenčina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - 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 a 5. 1)orpatients s rýchlo sa meniacim ťažké recidivujúce odosielajúcej roztrúsená skleróza definovaná 2 alebo viac vypnutie relapsami v jednom roku, a s 1 alebo viac gadolínium zvýšenie lézie v mozgu mri alebo významný nárast v t2 lézií zaťažení v porovnaní s predchádzajúcim posledných mri.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

sandoz pharmaceuticals d.d., slovinsko - fingolimod - 59 - immunopraeparata

Európska únia - slovenčina - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - 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 a 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.

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

bausch health ireland limited , Írsko - fingolimod - 59 - immunopraeparata

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

gedeon richter plc., maďarsko - fingolimod - 59 - immunopraeparata

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

reddy holding gmbh, nemecko - fingolimod - 59 - immunopraeparata

Európska únia - slovenčina - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - roztrúsená skleróza, recidivujúce-odosielajúcej - imunosupresíva - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

glenmark pharmaceuticals s.r.o., Česká republika - dimetyl-fumarát - 59 - immunopraeparata

Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

glenmark pharmaceuticals s.r.o., Česká republika - dimetyl-fumarát - 59 - immunopraeparata

Európska únia - slovenčina - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - roztrúsená skleróza - selektívne imunosupresíva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 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.