Union européenne - portugais - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - edoxaban tosilate - stroke; venous thromboembolism - agentes antitrombóticos - prevenção de acidente vascular cerebral e embolia sistêmica em pacientes adultos com fibrilação atrial não valvar (nvaf) com um ou mais fatores de risco, como insuficiência cardíaca congestiva, hipertensão, idade ≥ 75 anos, diabetes mellitus, acidente vascular cerebral prévio ou ataque isquêmico transitório (tia). tratamento da trombose venosa profunda (tvp) e embolia pulmonar (pe), e na prevenção da tvp recorrente e pe em adultos.

Union européenne - portugais - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil cloridrato de - neoplasias colorretais - agentes antineoplásicos - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Union européenne - portugais - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplasias do ovário - agentes antineoplásicos - ovário cancerlynparza é indicado como monoterapia para:tratamento de manutenção de pacientes adultos com avançadas (figo estágios iii e iv) brca1/2-mutações (germinativa e/ou somática) de alto grau epitelial de ovário, trompas de falópio ou peritoneal primário de câncer que estão em resposta (completa ou parcial) após a conclusão da primeira-linha platinum-base de quimioterapia. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 e 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. os doentes devem ter sido previamente tratados com uma antraciclina e um taxane no (neo)adjuvante ou metastático, configuração, a menos que os pacientes não eram adequadas para estes tratamentos (consulte a secção 5. pacientes com receptor de hormônio (rh)-positivo câncer de mama também deve ter progredido em ou após prévio terapêutica endócrina, ou ser considerado inadequado para terapia endócrina. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Union européenne - portugais - EMA (European Medicines Agency)

hra pharma rare diseases - mitotane - neoplasias de córtex adrenal - agentes antineoplásicos - tratamento sintomático de carcinoma cortical adrenal avançado (não resecável, metastático ou recidivado). o efeito de lysodren não-funcionais adrenal cortical carcinoma não é estabelecida.

Union européenne - portugais - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanoma - agentes antineoplásicos - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 e 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. não-pequenas de câncer de pulmão de células (nsclc)trametinib em combinação com o dabrafenib é indicado para o tratamento de pacientes adultos com avançado de células não-pequenas de câncer de pulmão com um braf v600 mutação.

Union européenne - portugais - EMA (European Medicines Agency)

accord healthcare s.l.u. - cloridrato de memantina - doença de alzheimer - outros medicamentos anti-demência - tratamento de pacientes com doença de alzheimer moderada a grave.

Union européenne - portugais - EMA (European Medicines Agency)

takeda pharma a/s - citrato de ixazomib - mieloma múltiplo - agentes antineoplásicos - ninlaro em associação com lenalidomida e dexametasona está indicado para o tratamento de pacientes adultos com mieloma múltiplo que receberam pelo menos uma terapia anterior.

Union européenne - portugais - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - carcinoma, pulmão de células não pequenas - antineoplásicos e imunomoduladores, anticorpos monoclonais - nivolumab bms é indicado para o tratamento de câncer de pulmão de células não pequenas pequenas localmente avançadas ou metastásicas (nsclc) após quimioterapia anterior em adultos.

Union européenne - portugais - EMA (European Medicines Agency)

hexal ag  - rivastigmina - dementia; alzheimer disease; parkinson disease - psychoanaleptics, - tratamento sintomático da demência de alzheimer leve a moderadamente grave. tratamento sintomático de leve a moderadamente grave demência em pacientes com a doença de parkinson idiopática.

Union européenne - portugais - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel hidrogen sulfato - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - agentes antitrombóticos - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. prevenção de aterotrombóticos e de eventos tromboembólicos em atrial fibrillationin pacientes adultos com fibrilação atrial que tenham pelo menos um fator de risco para eventos vasculares não são adequados para o tratamento com vitamina-k antagonistas e que têm um baixo risco de sangramento, o clopidogrel é indicado em combinação com asa para a prevenção de aterotrombóticos e eventos tromboembólicos, incluindo acidente vascular cerebral.