Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - clorhidrato de cinacalcet - el hiperparatiroidismo - homeostasis del calcio - secundaria hyperparathyroidismadultstreatment de hiperparatiroidismo secundario (hpt) en pacientes adultos con enfermedad renal en etapa final (esrd) en el mantenimiento de la terapia de diálisis. pediátrica populationtreatment de hiperparatiroidismo secundario (hpt) en niños de 3 años de edad y mayores con enfermedad renal en etapa final (esrd) en el mantenimiento de la terapia de diálisis en los cuales hpt secundario no está adecuadamente controlada con el estándar de cuidado de la terapia (véase la sección 4. cinacalcet accordpharma puede ser utilizado como parte de un régimen terapéutico, incluyendo los captores de fósforo y/o esteroles de vitamina d, según corresponda (véase la sección 5. carcinoma paratiroideo y el hiperparatiroidismo primario en adultsreduction de la hipercalcemia en pacientes adultos con:carcinoma paratiroideo. primaria hpt para quien la paratiroidectomía se indica en la base de los niveles de calcio sérico (como definidos por las guías de tratamiento), pero en los que la paratiroidectomía no es clínicamente apropiado o está contraindicada.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - agentes antineoplásicos - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - agentes antitrombóticos - prevención del tromboembolismo venoso (tev) en pacientes adultos sometidos a cirugía electiva de reemplazo de cadera o rodilla. tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en los adultos. (see section 4. 4 for haemodynamically unstable pe patients. tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en los adultos. (see section 4. 4 para hemodinámicamente inestable pe pacientes). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en los adultos. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 y 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. tratamiento de la trombosis venosa profunda (tvp) y embolia pulmonar (pe), y la prevención de la recurrencia de la tvp y de la ep en los adultos. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas en diabetes - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - inmunoestimulantes, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - neoplasmas prostáticos - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - fampridina - esclerosis múltiple - otras drogas del sistema nervioso - fampridine accord is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7).

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - agentes antineoplásicos - gastrointestinal stromal tumour (gist)sunitinib accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sunitinib accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sunitinib accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pnet) with disease progression in adults.

Unión Europea - español - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioedemas, hereditario - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

España - español - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare, s.l.u - oxaliplatino - excipientes: lactosa monohidrato - otros agentes antineoplÁsicos - compuestos del platino - oxaliplatino