Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

merck sharp & dohme b.v. - interferão alfa-2b - carcinoid tumor; leukemia, hairy cell; lymphoma, follicular; hepatitis b, chronic; hepatitis c, chronic; leukemia, myelogenous, chronic, bcr-abl positive; melanoma; multiple myeloma - immunostimulants, - hepatite crônica btreatment de pacientes adultos com hepatite b crônica associada com evidência de hepatite-b replicação viral (presença de dna de hepatite b e vírus (hbv-dna) e a hepatite b antígeno (hbeag), elevados de alanina aminotransferase (alt) e histologicamente comprovada ativa a inflamação do fígado e / ou fibrose. hepatite crônica antes de iniciar o tratamento com introna, consideração deve ser dada para os resultados de ensaios clínicos comparando introna com interferon peguilado. adultos patientsintrona é indicado para o tratamento de doentes adultos com hepatite c crónica, que têm valores elevados de transaminases sem descompensação hepática e que são positivos para hepatite c vírus de rna (hcv-rna). a melhor maneira de usar introna nesta indicação é em combinação com a ribavirina,. crianças de três anos de idade e mais velhos e adolescentsintrona é indicado, em um regime combinado com ribavirina para o tratamento de crianças de três anos de idade e mais velhas e adolescentes, que têm hepatite c crônica, não tratados previamente, sem descompensação hepática, e que são positivo para hcv-rna. quando a decisão de não adiar o tratamento até a idade adulta, é importante considerar que a terapia de combinação induziu uma inibição do crescimento que resultou na redução de final de adultos altura em alguns pacientes. a decisão de tratamento deve ser feita caso-a-caso. peludo-célula leukaemiatreatment de pacientes com cabeludo célula leucemia. mielóide crônica leukaemiamonotherapytreatment de pacientes adultos com filadélfia-cromossomo - ou bcr/abl-translocação-positivo crônica leucemia mielóide. a experiência clínica indica que um hematológica e citogenética maior / menor resposta é obtido na maioria dos pacientes tratados. um grande resposta citogenética é definida por < 34 % ph+ leukaemic células na medula óssea, enquanto que uma menor resposta é ≥ 34 %, mas < 90 % ph+ células na medula. combinação therapythe combinação de interferon alfa-2b e cytarabine (ara-c), administrada durante os primeiros 12 meses de tratamento tem sido demonstrado para aumentar significativamente a taxa de grandes citogenético de respostas e para prolongar significativamente a sobrevida global em três anos, quando comparado com interferon alfa-2b em monoterapia. vários myelomaas terapia de manutenção em pacientes que atingiram o objetivo remissão (mais de 50% de redução na proteína do mieloma múltiplo) após a primeira quimioterapia de indução. atual experiência clínica indica que a terapia de manutenção com interferon alfa-2b, que prolonga a fase de platô; no entanto, os efeitos na sobrevida global não foi conclusivamente demonstrado. folicular lymphomatreatment de alta-tumor-carga folicular linfoma, como adjunto adequada combinação de quimioterapia de indução como um pique-como o regime de. alta tumor carga é definida como tendo pelo menos um dos seguintes: volumoso tumor de massa (> 7 cm), o envolvimento de três ou mais nodal sites (cada > 3 cm), sintomas sistêmicos (perda de peso > 10 %, febre > 38°c por mais de oito dias, ou suores noturnos), esplenomegalia além do umbigo, de grandes órgãos de obstrução ou síndrome de compressão, orbital ou epidural, envolvimento, derrame seroso ou leucemia. carcinóide tumourtreatment de tumores carcinóides com linfonodos, fígado ou metástases e com 'síndrome carcinóide'. maligno melanomaas terapia adjuvante em pacientes que estão livres da doença após a cirurgia, mas estão em alto risco de recorrência sistêmica, e. pacientes com primário ou recorrente (clínico ou patológico) da linfa-nó.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

bayer ag - telmisartan - hipertensão - agentes que atuam no sistema renina-angiotensina - hypertensiontreatment da hipertensão essencial em adultos. sistema circulatório preventionreduction de morbidade cardiovascular em pacientes com:manifesto aterotrombóticos doença cardiovascular (história de doença coronariana, acidente vascular cerebral ou doença arterial periférica) ou;diabetes mellitus do tipo 2 com documentados alvo lesão de órgãos-.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

bayer ag - octocog alfa - hemofilia a - anti-hemorrágicos - tratamento e profilaxia do sangramento em pacientes com hemofilia a (deficiência congênita de fator viii). kovaltry pode ser usado para todas as faixas etárias.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

bayer ag - telmisartan - hipertensão - agentes que atuam no sistema renina-angiotensina - hypertensiontreatment da hipertensão essencial em adultos. sistema circulatório preventionreduction de morbidade cardiovascular em pacientes com:manifesto aterotrombóticos doença cardiovascular (história de doença coronariana, acidente vascular cerebral ou doença arterial periférica) ou;diabetes mellitus do tipo 2 com documentados alvo lesão de órgãos-.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

bayer ag - vericiguat - insuficiência cardíaca - terapia cardíaca - treatment of symptomatic chronic heart failure.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - imunossupressores - rheumatoid arthritishukyndra in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab tem sido mostrado para reduzir a taxa de progressão do dano articular, como medido por raio-x e para melhorar a função física, quando administrado em combinação com metotrexato. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab não foi estudado em pacientes com idade inferior a 2 anos. enthesitis-related arthritishukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab tem sido mostrado para reduzir a taxa de progressão das lesões das articulações periféricas, conforme medido pelo raio-x em pacientes com poliarticular simétrica subtipos da doença (consulte a secção 5. 1) e para melhorar a função física. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 e 5. crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehukyndra is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitishukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - imunossupressores - rheumatoid arthritislibmyris in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. adalimumab tem sido mostrado para reduzir a taxa de progressão do dano articular, como medido por raio-x e para melhorar a função física, quando administrado em combinação com metotrexato. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. adalimumab não foi estudado em pacientes com idade inferior a 2 anos. enthesitis-related arthritislibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. adalimumab tem sido mostrado para reduzir a taxa de progressão das lesões das articulações periféricas, conforme medido pelo raio-x em pacientes com poliarticular simétrica subtipos da doença e melhorar a função física. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 e 5. crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaselibmyris is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitislibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

takeda manufacturing austria ag - proteína c humana - purpura fulminans; protein c deficiency - agentes antitrombóticos - ceprotin is indicated for prophylaxis and treatment of  purpura fulminans  coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein c deficiency.

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

hexal ag - epoetina alfa - anemia; kidney failure, chronic; cancer - preparações antianêmicas - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. , o tratamento da anemia e redução de transfusão de requisitos em doentes adultos a receber quimioterapia para tumores sólidos, linfoma maligno ou mieloma múltiplo e em risco de transfusão de acordo com a avaliação do paciente estado geral (e. cardiovascular pré-existente anemia no início da quimioterapia).

Unjoni Ewropea - Portugiż - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - agalsidase alfa - doença de fabry - outro aparelho digestivo e metabolismo produtos, - replagal é indicado para a terapia de reposição enzimática a longo prazo em pacientes com diagnóstico confirmado de doença de fabry (deficiência de α-galactosidase-a).