Шпанија - Шпански - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

mylan ire healthcare limited - tramadol hidrocloruro - cÁpsula dura de liberaciÓn prolongada - 200 mg - tramadol hidrocloruro 200 mg - tramadol

Шпанија - Шпански - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

mylan ire healthcare limited - tramadol hidrocloruro - cÁpsula dura de liberaciÓn prolongada - 50 mg - tramadol hidrocloruro 50 mg - tramadol

Шпанија - Шпански - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

mylan ire healthcare limited - bentazepam - comprimido - 25 mg - bentazepam 25 mg - bentazepam

Шпанија - Шпански - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

mylan ire healthcare limited - colecalciferol - comprimido - 800 ui - colecalciferol 800 ui - colecalciferol

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ireland limited - azacitidina - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - agentes antineoplásicos - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ireland limited - el trióxido de arsénico - leucemia, promielocítica, aguda - agentes antineoplásicos - el trióxido de arsénico mylan está indicado para la inducción de la remisión, y la consolidación en pacientes adultos con:- recién diagnosticados de bajo a intermedio de riesgo de la leucemia promielocítica aguda (apl) (recuento de glóbulos blancos, ≤ 10 x 103/µl), en combinación con el ácido trans-retinoico (atra)- recaída/refractario de la leucemia promielocítica aguda (apl) (tratamiento previo debe haber incluido un retinoide y quimioterapia), caracterizado por la presencia de la t(15;17) translocación y/o la presencia de la leucemia promielocítica aguda/receptor de ácido retinoico alfa (pml/rar alfa) gen. la tasa de respuesta de otros subtipos de leucemia mielógena aguda a trióxido de arsénico no ha beenexamined.

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - agentes antitrombóticos - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan 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.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention 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. paediatric population treatment 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. paediatric population treatment 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.

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas en diabetes - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride mylan is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. sitagliptin/metformin hydrochloride mylan is indicated in combination with a sulphonylurea (i. , terapia de combinación triple) como complemento a la dieta y ejercicio en pacientes inadecuadamente controlados en su máxima dosis tolerada de metformina y una sulfonilurea. sitagliptin/metformin hydrochloride mylan is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparg) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparg agonist. sitagliptin/metformin hydrochloride mylan is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberculosis, resistente a múltiples fármacos - antimicobacterianos - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). se debe dar consideración a las directrices oficiales sobre el uso adecuado de agentes antibacterianos.

Европска Унија - Шпански - EMA (European Medicines Agency)

mylan ire healthcare limited - fondaparinux sódico - venous thrombosis; pulmonary embolism; myocardial infarction; angina, unstable - agentes antitrombóticos - 5 mg / 0. 3 ml y 2. 5 mg / 0. 5-ml solution for injectionprevention of venous thromboembolic events (vte) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. la prevención de la tromboembolia venosa en adultos sometidos a cirugía abdominal que se consideran en alto riesgo de complicaciones tromboembólicas, tales como los pacientes sometidos abdominales de la cirugía de cáncer. la prevención de la tromboembolia venosa en adultos médica de los pacientes que se consideran en alto riesgo de etv y que están inmovilizados debido a la fase aguda de la enfermedad, tales como la insuficiencia cardiaca y / o respiratoria aguda trastornos y / o infecciosa aguda o enfermedad inflamatoria. el tratamiento de adultos con infección aguda sintomática espontánea superficial-trombosis venosa de las extremidades inferiores, sin la consiguiente trombosis venosa profunda. 5 mg / 0. 5-ml solution for injectiontreatment of unstable angina or non-st-segment-elevation myocardial infarction (ua/nstemi) in adult patients for whom urgent (< 120 mins) invasive management (pci) is not indicated. de miocardio (iam) en pacientes adultos que son gestionados con trombolíticos o que inicialmente van a recibir ninguna otra forma de terapia de reperfusión. 5 mg / 0. 4-ml, 7. 5 mg / 0. 6-ml y 10 mg/0. 8-ml solution for injectiontreatment of adults with acute deep-vein thrombosis (dvt) and treatment of acute pulmonary embolism (pe), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.