Ευρωπαϊκή Ένωση - Ισπανικά - 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.

Ευρωπαϊκή Ένωση - Ισπανικά - 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.

Ευρωπαϊκή Ένωση - Ισπανικά - 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.

Ισπανία - Ισπανικά - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare s.l.u. - linezolid - comprimido recubierto con pelÍcula - 600 mg - linezolid 600 mg - linezolid

Ισπανία - Ισπανικά - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare s.l.u. - eplerenona - comprimido recubierto con pelÍcula - 25 mg - eplerenona 25 mg - eplerenona

Ισπανία - Ισπανικά - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare s.l.u. - eplerenona - comprimido recubierto con pelÍcula - 50 mg - eplerenona 50 mg - eplerenona

Ισπανία - Ισπανικά - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

accord healthcare s.l.u. - bivalirudina - polvo para concentrado para solucion inyectable y para perfusion - 250 mg - bivalirudina 250 mg - bivalirudina

Ευρωπαϊκή Ένωση - Ισπανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - aripiprazol - schizophrenia; bipolar disorder - psicolépticos - aripiprazol accord está indicado para el tratamiento de la esquizofrenia en adultos y en adolescentes de 15 años en adelante. aripiprazole acuerdo está indicado para el tratamiento de moderada a severa episodios maníacos en el trastorno bipolar i y para la prevención de un nuevo episodio maníaco en los adultos que experimentaron predominantemente maníacos y episodios de cuyos episodios maníacos respondió a aripiprazole tratamiento. aripiprazole acuerdo está indicado para el tratamiento de hasta 12 semanas de moderada a severa episodios maníacos en el trastorno bipolar i en adolescentes de 13 años de edad y mayores.

Ευρωπαϊκή Ένωση - Ισπανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabina - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - agentes antineoplásicos - capecitabina accord está indicado para el tratamiento adyuvante de pacientes después de la cirugía de cáncer de colon en estadio iii (dukes 'stage-c). capecitabine accord está indicado para el tratamiento de cáncer colorrectal metastásico. capecitabine accord está indicado para el tratamiento de primera línea del cáncer gástrico avanzado en combinación con un platino-basada en régimen de. capecitabine accord en combinación con docetaxel está indicado para el tratamiento de pacientes con localmente avanzado o metastásico, cáncer de mama, después del fracaso de la quimioterapia citotóxica. la terapia anterior debería haber incluido una antraciclina. capecitabine accord también está indicado como monoterapia para el tratamiento de pacientes con localmente avanzado o metastásico, cáncer de mama, después del fracaso de los taxanos y antraciclinas contiene régimen de quimioterapia o de los cuales más de antraciclina, la terapia no está indicado.

Ευρωπαϊκή Ένωση - Ισπανικά - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. excepto en recién diagnosticados de lmc en fase crónica, no existen ensayos controlados que demuestran un beneficio clínico o el aumento de la supervivencia para estas enfermedades. .