Uniunea Europeană - română - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxismal - imunosupresoare selective - 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.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

almac pharma services (ireland) limited - irlanda - ravulizumabum - conc. pt. sol. perf. - 1100 mg/11 ml - imunosupresoare imunosupresoare selective

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

almac pharma services (ireland) limited - irlanda - ravulizumabum - conc. pt. sol. perf. - 300mg/3ml - imunosupresoare imunosupresoare selective

Uniunea Europeană - română - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohn boala - imunostimulante, - tratamentul activă moderată până la severă boala crohn pentru reducerea semnelor și a simptomelor, și de inducție și de întreținere a răspuns susținut la tratament și remisie, la pacienții care nu au răspuns, în ciuda unei cure complete și adecvate de terapie cu corticosteroizi și imunosupresoare; sau care nu tolerează sau prezintă contraindicații pentru astfel de terapii.

Uniunea Europeană - română - 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.

Uniunea Europeană - română - 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.

Uniunea Europeană - română - EMA (European Medicines Agency)

biogen idec ltd - daclizumab - scleroză multiplă - imunosupresoare - zinbryta este indicat la pacienții adulți pentru tratamentul formelor recurente de scleroză multiplă (rms).

Uniunea Europeană - română - EMA (European Medicines Agency)

roche registration ltd. - daclizumab - graft rejection; kidney transplantation - imunosupresoare - zenapax este indicat pentru profilaxia de respingere acută de organe în de novo transplantul grefei renale şi urmează să fie utilizat concomitent cu un regim de imunosupresoare, inclusiv ciclosporina si corticosteroizii la pacienţii care nu sunt imunizate extrem.

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

biogen (denmark) manufacturing aps - danemarca - natalizumabum - sol. inj. in seringa preumpluta - 150mg - imunosupresoare imunosupresoare selective

România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

biogen (denmark) manufacturing aps - danemarca - natalizumabum - conc. pt. sol. perf. - 20mg/ml - imunosupresoare imunosupresoare selective