Roctavian Europska Unija - hrvatski - EMA (European Medicines Agency)

roctavian

biomarin international limited - valoctocogene roxaparvovec - antihemorrhagics - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Elfabrio Europska Unija - hrvatski - EMA (European Medicines Agency)

elfabrio

chiesi farmaceutici s.p.a - pegunigalsidase alfa - fabry-ovu bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase).

Tyruko Europska Unija - hrvatski - EMA (European Medicines Agency)

tyruko

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - 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 i 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.