Europska Unija - hrvatski - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 300 mg/3 ml - 1 bočica sa 3 ml koncentrata za otopinu za infuziju sadrži 300 mg ravulizumaba (100 mg/ml)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 1100 mg/11 ml - 1 bočica sa 11 ml koncentrata za otopinu za infuziju sadrži 1100 mg ravulizumaba (100 mg/ml)

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

amicus pharma d.o.o. - ravulizumab - koncentrat za otopinu za infuziju - 300 mg/30 ml - 1 bočica sa 30 ml koncentrata za otopinu za infuziju sadrži 300 mg ravulizumaba (10 mg/ml)

Europska Unija - hrvatski - EMA (European Medicines Agency)

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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multipla skleroza - selektivni imunosupresivi - 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 i 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.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

medis international d.o.o. sarajevo - natalizumab - koncentrat za rastvor za infuziju - 300 mg/15 ml - 1 bočica sa 15 ml koncetrata za rastvor za infuziju sadrži: 300 mg natalizumaba

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratorios lesvi s.l. - dimetil fumarat - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - dimethyl fumarate neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

proton med d.o.o. banja luka - финголимод - kapsula, tvrda - 0,56 mg/1 kapsula - 1 kapsula, tvrda sadrži: 0,5 mg fingolimoda (u obliku 0,56 mg fingolimod hidrohlorida)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

medochemie ltd., constatinoupoleos str. 1-10, limassol, cipar - fingolimodklorid - kapsula, tvrda - 0,5 mg - urbroj: svaka kapsula sadrži 0,5 mg fingolimoda (u obliku fingolimodklorida)