Unia Europejska - portugalski - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; microscopic polyangiitis; wegener granulomatosis - agentes antineoplásicos - riximyo is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)riximyo is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. riximyo maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. riximyo monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. riximyo is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. riximyo in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). chronic lymphocytic leukaemia (cll)riximyo in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia. apenas dados limitados sobre a eficácia e segurança para os pacientes previamente tratados com anticorpos monoclonais, incluindo rituximab ou pacientes refratários ao anterior rituximab além de quimioterapia. consulte a seção 5,. 1 para mais informações. rheumatoid arthritisriximyo in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (dmard) including one or more tumour necrosis factor (tnf) inhibitor therapies. rituximab 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. granulomatosis with polyangiitis and microscopic polyangiitisriximyo, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). riximyo, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisriximyo is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unia Europejska - portugalski - EMA (European Medicines Agency)

sandoz gmbh - rituximab - lymphoma, non-hodgkin; arthritis, rheumatoid; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis; microscopic polyangiitis; pemphigus - agentes antineoplásicos - rixathon is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rixathon is indicated for the treatment of previously untreated adult patients with stage iii-iv follicular lymphoma in combination with chemotherapy. rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. rixathon monotherapy is indicated for treatment of adult patients with stage iii-iv follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. rixathon is indicated for the treatment of adult patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. rixathon in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥ 6 months to < 18 years old) with previously untreated advanced stage cd20 positive diffuse large b-cell lymphoma (dlbcl), burkitt lymphoma (bl)/burkitt leukaemia (mature b-cell acute leukaemia) (bal) or burkitt-like lymphoma (bll). leucemia linfocítica crônica (cll)rixathon em combinação com a quimioterapia é indicada para o tratamento de pacientes não tratados previamente e recidivado/refratário leucemia linfocítica crônica. apenas dados limitados sobre a eficácia e segurança para os pacientes previamente tratados com anticorpos monoclonais, incluindo rituximab ou pacientes refratários ao anterior rituximab além de quimioterapia. consulte a seção 5,. 1 para mais informações. artrite arthritisrixathon em combinação com o metotrexato é indicado para o tratamento de pacientes adultos com graves de artrite reumatóide activa, que tiveram uma resposta inadequada ou intolerância a outros modificadores da doença drogas anti-reumáticas (dmcd) incluindo um ou mais de factor de necrose tumoral (tnf) inibidor de terapias. rituximab 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. granulomatosis with polyangiitis and microscopic polyangiitisrixathon, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa). rixathon, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥ 2 to < 18 years old) with severe, active gpa (wegener’s) and mpa. pemphigus vulgarisrixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (pv).

Unia Europejska - portugalski - EMA (European Medicines Agency)

accord healthcare s.l.u. - acetato de abiraterona - neoplasias prostáticas - terapia endócrina - abiraterone accord is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Unia Europejska - portugalski - EMA (European Medicines Agency)

mylan ireland limited - acetato de abiraterona - neoplasias prostáticas - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Unia Europejska - portugalski - EMA (European Medicines Agency)

krka, d.d., novo mesto - acetato de abiraterona - neoplasias prostáticas - terapia endócrina - abiraterone krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt) (see section 5. 1)the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. 1)the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Portugalia - portugalski - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

angelini pharma portugal, unipessoal lda - prednisolona - comprimido - 20 mg - prednisolona 20 mg - prednisolone - n/a - duração do tratamento: longa duração

Portugalia - portugalski - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

angelini pharma portugal, unipessoal lda - prednisolona - comprimido - 5 mg - prednisolona 5 mg - prednisolone - n/a - duração do tratamento: longa duração

Unia Europejska - portugalski - EMA (European Medicines Agency)

le vet b.v. - prednisolona - corticosteróides para uso sistémico, simples, prednisolona, sistêmica preparações hormonais, excl. sexo hormônios e insulina - cavalos - alívio de parâmetros inflamatórios e clínicos associados à obstrução da via aérea recorrente (rao) em cavalos, em combinação com controle ambiental.

Brazylia - portugalski - ANVISA (Agência Nacional de Vigilância Sanitária)

achÉ laboratÓrios farmacÊuticos s.a - prednisolona - glicocorticoides sistemicos

Brazylia - portugalski - ANVISA (Agência Nacional de Vigilância Sanitária)

ems s/a - prednisolona - glicocorticoides sistemicos