Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - erlotinib - carcinoma, non-small-cell lung; pancreatic neoplasms - agentes antineoplásicos - não-pequenas de câncer de pulmão de células (nsclc)tarceva é também indicado para alternar o tratamento de manutenção em pacientes com localmente avançado ou metastático de células não-pequenas de câncer de pulmão com egfr mutações ativadoras e doença estável após a quimioterapia de primeira linha. tarceva é também indicado para o tratamento de pacientes com localmente avançado ou metastático de células não-pequenas de câncer de pulmão, após falha de pelo menos um regime de quimioterapia prévia. em pacientes com tumores sem egfr mutações ativadoras, tarceva é indicado quando outras opções de tratamento não são considerados adequados. quando a prescrição de tarceva, fatores associados prolongada sobrevivência deve ser levado em conta. nenhum benefício de sobrevivência ou de outros clinicamente relevantes efeitos do tratamento tem sido demonstrada em pacientes com receptor de fator de crescimento epidérmico (egfr)-ihc - negativa de tumores.. pâncreas cancertarceva em combinação com gemcitabine é indicado para o tratamento de pacientes com câncer de pâncreas metastático. quando a prescrição de tarceva, fatores associados prolongada sobrevivência deve ser levado em conta.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - ocrelizumab - esclerose múltipla - imunossupressores - tratamento de pacientes adultos com formas recorrentes de esclerose múltipla (rms) com doença ativa definida por características clínicas ou de imagem. o tratamento de pacientes adultos com início primária progressiva esclerose múltipla (ppms) em termos de duração da doença e o nível de deficiência, com recursos de imagem característica de atividade inflamatória.

Европейски съюз - португалски - 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.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemofilia a - anti-hemorrágicos - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra pode ser usado em todos os grupos de idade.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - linfoma de células b - agentes antineoplásicos - polivy em combinação com bendamustine e o rituximab é indicado para o tratamento de pacientes adultos com recidivado/refratário difuso de grandes células b linfoma (dlbcl), que não são candidatos a transplante de células tronco hematopoiéticas. polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - agentes antineoplásicos - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza humana - antivirais para uso sistêmico - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - neoplasias do peito - agentes antineoplásicos - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - atrofia muscular, espinhal - outras drogas para distúrbios do sistema músculo-esquelético - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Европейски съюз - португалски - EMA (European Medicines Agency)

roche registration gmbh - satralizumab - neuromyelitis optica - imunossupressores - satralizumab (enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (ist) for the treatment of neuromyelitis optica spectrum disorders (nmosd) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 igg (aqp4-igg) seropositive.