União Europeia - português - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinúria, paroxística - imunossupressores seletivos - 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.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

alexion servicos e farmaceutica do brasil ltda - ravulizumabe - outros prods nao enquadrados em classe terapeutica especif

União Europeia - português - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - doença de crohn - immunostimulants, - tratamento da activa moderada a grave doença de crohn para a redução de sintomas e sinais, e a indução e manutenção da sustentado de resposta e de remissão, em pacientes que não responderam, apesar de um completo e adequado de terapia com corticosteróides e imunossupressores; ou que são intolerantes ou que tenham contra-indicações médicas para tais terapias.

União Europeia - português - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - oftalmológicos - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

União Europeia - português - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmológicos - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

União Europeia - português - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmológicos - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).

União Europeia - português - EMA (European Medicines Agency)

novartis europharm limited - ranibizumab - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - oftalmológicos - lucentis é indicado em adultos para o tratamento de neovascular (úmida) degeneração macular relacionada à idade (amd)o tratamento da deficiência visual, devido a choroidal neovascularisation (cnv)o tratamento da deficiência visual, devido ao diabético macular, edema (dme)o tratamento da deficiência visual, devido à macular, edema secundário à oclusão da veia da retina (ramo rvo ou central rvo).

União Europeia - português - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinúria, paroxística - imunossupressores - soliris é indicado em adultos e crianças para o tratamento de:hemoglobinúria paroxística noturna (hpn). evidência de benefício clínico é demonstrado em pacientes com hemólise com sintoma clínico(s) indicativo de alta atividade de doença, independentemente de transfusão de história (consulte a secção 5. atípico hemolítica síndrome urêmico (ahus). soliris é indicado em adultos para o tratamento de:refractários generalizada miastenia gravis (gmg), em pacientes que são anti-receptor de acetilcolina (achr, em inglês) anticorpo positivo (consulte a secção 5. neuromielite óptica transtorno do espectro (nmosd) em pacientes que são anti-aquaporina-4 (aqp4) anticorpo positivo com um reincidente curso da doença.

União Europeia - português - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinúria, paroxística - imunossupressores - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidência de benefício clínico é demonstrado em pacientes com hemólise com sintoma clínico(s) indicativo de alta atividade de doença, independentemente de transfusão de história (consulte a secção 5.

União Europeia - português - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunossupressores - 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 e 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.