Union européenne - portugais - EMA (European Medicines Agency)

eckert ziegler radiopharma gmbh - yttrium (90y) chloride - imagem de radionuclídeos - radiofármaco de diagnóstico - para ser usado apenas para o radiomarcação de moléculas transportadoras, que foram especificamente desenvolvidas e autorizadas para radiomarcação com este radionuclídeo. radiopharmaceutical precursor - não se destina para uso direto em pacientes.

Union européenne - portugais - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - radiofármaco de diagnóstico - este medicamento é apenas para uso diagnóstico. axumin é indicado para tomografia por emissão de pósitrons (pet) de imagem para detectar a recorrência de câncer de próstata em homens adultos com suspeita de recorrência com base no sangue elevados antígeno específico da próstata (psa) após tratamento curativo primário.

Union européenne - portugais - 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).

Union européenne - portugais - EMA (European Medicines Agency)

merck europe b.v. - avelumab - tumores neuroendócrinos - outros agentes antineoplásicos, anticorpos monoclonais - bavencio é indicado como monoterapia para o tratamento de pacientes adultos com carcinoma de células merkel metastático (mcc). bavencio em combinação com axitinib é indicado para o tratamento de primeira linha de pacientes adultos com avançados de carcinoma de células renais (rcc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Union européenne - portugais - EMA (European Medicines Agency)

amgen technology (ireland) uc - bevacizumab - carcinoma, renal cell; peritoneal neoplasms; ovarian neoplasms; breast neoplasms; carcinoma, non-small-cell lung; fallopian tube neoplasms - agentes antineoplásicos - mvasi em combinação com a quimioterapia à base de fluoropirimidina é indicado para o tratamento de pacientes adultos com carcinoma metastático do cólon ou reto. mvasi em combinação com paclitaxel é indicado para o tratamento de primeira linha de doentes adultos com cancro da mama metastático. para mais informações sobre o status do receptor do fator de crescimento epidérmico humano (her2), consulte a seção 5. mvasi, além de platina-base de quimioterapia, é indicado para o tratamento de primeira linha de pacientes adultos com metastáticos avançada, metastático ou recorrente de células não-pequenas de câncer de pulmão diferente predominantemente de células escamosas de histologia. mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. mvasi, em combinação com carboplatin e o paclitaxel é indicado para o tratamento de pacientes adultos com avançadas (federação internacional de ginecologia e obstetrícia (figo) fases iii-b, iii-c, iv) epitelial de ovário, trompas de falópio, ou primário peritoneal câncer. mvasi, em combinação com carboplatin e gemcitabine ou em combinação com carboplatin e paclitaxel, é indicado para o tratamento de pacientes adultos com a primeira recorrência da platina-sensível epiteliais do ovário, da trompa de falópio ou peritoneal primário de câncer que não receberam terapêutica prévia com bevacizumabe ou outros inibidores de vegf ou do receptor de vegf-alvo agentes. mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor-targeted agents. mvasi, em combinação com paclitaxel e cisplatina ou, em alternativa, paclitaxel e topotecan em pacientes que não podem receber platina terapia, é indicado para o tratamento de pacientes adultos com persistente, recorrente ou metastático, o carcinoma do colo do útero.

Union européenne - portugais - 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).

Union européenne - portugais - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - agentes antineoplásicos - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq como monoterapia é indicado para o tratamento de pacientes adultos com localmente avançado ou metastático, nsclc após quimioterapia prévia. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq como monoterapia é indicado para o tratamento de pacientes adultos com localmente avançado ou metastático, nsclc após quimioterapia prévia. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Union européenne - portugais - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - agentes antineoplásicos - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Union européenne - portugais - EMA (European Medicines Agency)

takeda pharma a/s - brigatinib - carcinoma, pulmão de células não pequenas - agentes antineoplásicos - alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase alkpositive advanced nsclc previously treated with crizotinib.

Union européenne - portugais - EMA (European Medicines Agency)

pharmaand gmbh - rucaparib camsylate - neoplasias do ovário - agentes antineoplásicos - rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. rubraca é indicado como monoterapia para o tratamento de manutenção de pacientes adultos com platina-sensível recaiu alto grau de epiteliais do ovário, da trompa de falópio, ou peritoneal primário de câncer que estão em resposta (total ou parcial) de platina baseado em quimioterapia.