Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

delorbis pharmaceuticals ltd. - cipru - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Evropská unie - rumunština - EMA (European Medicines Agency)

mylan ireland limited - fingolimod clorhidrat de - scleroză multiplă, scleroză multiplă recurent-remisivă - imunosupresoare - 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 și 5. 1)orpatients cu evoluție rapidă severă scleroză multiplă recurentă remisivă definită prin 2 sau mai multe recidive care produc invaliditate într-un an și cu 1 sau mai multe leziuni evidențiate cu gadoliniu la irm craniană sau o creștere semnificativă a încărcării leziunilor t2 comparativ cu o irm anterioară recentă.

Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

novartis pharma gmbh - germania - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Evropská unie - rumunština - EMA (European Medicines Agency)

mylan ireland limited - fingolimod clorhidrat de - scleroză multiplă, scleroză multiplă recurent-remisivă - imunosupresoare - 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 și 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.

Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

betapharm arzneimittel gmbh - germania - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

delorbis pharmaceuticals ltd. - cipru - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Rumunsko - rumunština - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmadox healthcare ltd. - malta - fingolimodum - caps. - 0,5mg - imunosupresoare imunosupresoare selective

Evropská unie - rumunština - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - scleroză multiplă - imunosupresoare selective - 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 și 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.

Evropská unie - rumunština - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresoare - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease 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 și 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.