União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - dicloridrato de pramipexole monohidratado - parkinson disease; restless legs syndrome - anti-parkinson - o acordo de pramipexol é indicado em adultos para o tratamento dos sinais e sintomas da doença de parkinson idiopática, isoladamente (sem levodopa) ou em combinação com levodopa, i. ao longo da doença, até os estágios tardios quando o efeito da levodopa desaparecer ou se torna inconsistente e as flutuações do efeito terapêutico ocorrem (flutuações de fim de dose ou "on-off").

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agentes antineoplásicos - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - agentes antineoplásicos - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - icatibant acetate - angioedemas, hereditário - 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.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas em 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.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazole - schizophrenia; bipolar disorder - psicolepticos - o aripiprazole accord está indicado para o tratamento da esquizofrenia em adultos e em adolescentes de 15 anos ou mais. aripiprazole acordo é indicado para o tratamento de moderados a graves episódios maníacos em transtorno bipolar i e para a prevenção de um novo episódio de mania em adultos que sofreram predominantemente episódios maníacos e cujos episódios maníacos respondeu ao aripiprazol tratamento. aripiprazole acordo é indicado para o tratamento de até 12 semanas de moderados a graves episódios maníacos em transtorno bipolar i em adolescentes com idade de 13 anos e mais velhos.

União Europeia - português - 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.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomida - mieloma múltiplo - imunossupressores - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) é indicado para o tratamento de pacientes adultos não tratados previamente com mieloma múltiplo que não são elegíveis para transplante. a lenalidomida acordo, em combinação com dexametasona é indicado para o tratamento de mieloma múltiplo em pacientes adultos que receberam pelo menos uma terapêutica prévia. follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - cloridrato de cinacalcet - o hiperparatiroidismo - homeostase de cálcio - secundário hyperparathyroidismadultstreatment de hiperparatiroidismo secundário (hpt) em pacientes adultos com insuficiência renal em estágio terminal (irct) em terapia de diálise de manutenção. pediátrica populationtreatment de hiperparatiroidismo secundário (hpt) em crianças com idades entre 3 anos e mais de idade com insuficiência renal em estágio terminal (irct) em manutenção terapia de diálise em quem hpt secundário não é adequadamente controlada com o padrão de cuidados de terapia (ver secção 4,. cinacalcet accordpharma pode ser usado como parte de um regime terapêutico, incluindo fosfato de fichários e/ou vitamina d e os esteróis, como adequado (consulte a secção 5. carcinoma de paratireóide e hiperparatiroidismo primário em adultsreduction de hypercalcaemia em pacientes adultos com:carcinoma de paratireóide. hpt primário para quem parathyroidectomy seria indicado, na base dos níveis séricos de cálcio (conforme definido pelas respectivas diretrizes para o tratamento), mas em quem parathyroidectomy não é clinicamente apropriado ou é contra-indicado.

União Europeia - português - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - 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.