European Union - Spanish - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - agentes antineoplásicos - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. los pacientes con egfr o alk positivo tumor mutaciones debe también han recibido terapia dirigida antes de recibir keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

European Union - Spanish - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - el ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - agentes antineoplásicos - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 y 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

European Union - Spanish - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - agentes antineoplásicos - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

European Union - Spanish - EMA (European Medicines Agency)

orion corporation - la levodopa, carbidopa, entacapone - mal de parkinson - medicamentos contra el parkinson - stalevo está indicado para el tratamiento de pacientes adultos con enfermedad de parkinson y fluctuaciones motoras de final de dosis no estabilización de levodopa / dopa-decarboxilasa (ddc)-tratamiento del inhibidor de.

European Union - Spanish - EMA (European Medicines Agency)

orion corporation - la levodopa, carbidopa, entacapone - mal de parkinson - medicamentos contra el parkinson - corbilta está indicado para el tratamiento de pacientes adultos con enfermedad de parkinson y las fluctuaciones motoras al final de la dosis no estabilizadas en el tratamiento con inhibidores de levodopa / dopa descarboxilasa (ddc).

European Union - Spanish - EMA (European Medicines Agency)

nova laboratories ireland limited - espironolactona - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 y 5.

European Union - Spanish - EMA (European Medicines Agency)

diurnal europe b.v. - hidrocortisona - insuficiencia suprarrenal - corticosteroides para uso sistémico - la terapia de reemplazo de insuficiencia suprarrenal en bebés, niños y adolescentes (desde el nacimiento a < 18 años de edad).

European Union - Spanish - EMA (European Medicines Agency)

amneal pharma europe ltd - la levodopa, carbidopa - mal de parkinson - medicamentos contra el parkinson - tratamiento sintomático de pacientes adultos con enfermedad de parkinson.

European Union - Spanish - EMA (European Medicines Agency)

schering-plough europe - interferón alfa-2b - hepatitis c, chronic; hepatitis b, chronic - inmunoestimulantes, - hepatitis b crónica: tratamiento de pacientes adultos con hepatitis b crónica asociada con la evidencia de la hepatitis b, la replicación viral (presencia de adn-vhb y hbeag), elevación de la alanina aminotransferasa (alt) y histológicamente probada hepática activa de la inflamación y/o fibrosis. hepatitis c crónica:pacientes adultos:introna está indicado para el tratamiento de pacientes adultos con hepatitis c crónica que tiene niveles elevados de transaminasas sin descompensación hepática y que sean positivos para el arn vhc o anti-vhc (véase la sección 4. la mejor manera de utilizar introna en esta indicación es en combinación con ribavirina. niños y adolescentes:introna está diseñado para su uso, en un régimen de combinación con ribavirina, para el tratamiento de niños y adolescentes de 3 años de edad y mayores, que tienen hepatitis c crónica, no tratados previamente, sin descompensación hepática, y que son positivos para el vhc-arn. la decisión de tratar debe hacerse sobre una base de caso por caso, teniendo en cuenta cualquier evidencia de progresión de la enfermedad, tales como la inflamación hepática y fibrosis, así como factores pronósticos de respuesta, el vhc de genotipo y carga viral. el beneficio esperado del tratamiento debe ser sopesado contra la seguridad de los hallazgos observados en la infancia de los sujetos en los ensayos clínicos (ver secciones 4. 4, 4. 8 y 5.

European Union - Spanish - EMA (European Medicines Agency)

bial - portela ca, s.a. - acetato de eslicarbazepina - epilepsia - los antiepilépticos, - exalief está indicado como terapia adyuvante en adultos con convulsiones de inicio parcial con o sin generalización secundaria.