Европска Унија - Шпански - EMA (European Medicines Agency)

janssen-cilag international n.v.   - macitentan - hipertensión, pulmonar - los antihipertensivos,los - opsumit, como monoterapia o en combinación, está indicado para el tratamiento a largo plazo de la hipertensión arterial pulmonar (hap) en pacientes adultos de la clase funcional (fc) ii a iii de la oms.. la eficacia se ha demostrado en un pah la población, incluyendo a idiopática y hereditarias de la pah, pah asociados con trastornos del tejido conectivo, y la hap asociada con corrección simple enfermedad cardíaca congénita.

Европска Унија - Шпански - EMA (European Medicines Agency)

pfizer limited - celecoxib - poliposis adenomatosa coli - agentes antineoplásicos - onsenal está indicado para la reducción del número de pólipos adenomatosos intestinales en la poliposis adenomatosa familiar (fap), como complemento de la cirugía y la vigilancia endoscópica adicional (ver sección 4).. el efecto de onsenal inducida por la reducción de pólipo carga sobre el riesgo de cáncer intestinal no ha sido demostrada (ver secciones 4. 4 y 5.

Европска Унија - Шпански - EMA (European Medicines Agency)

les laboratoires servier - ivabradina clorhidrato - angina pectoris; heart failure - terapia cardiaca - tratamiento sintomático de la angina estable crónica de pecho ivabradina está indicado para el tratamiento sintomático de crónica estable angina de pecho en adultos de enfermedad coronaria con ritmo sinusal normal y ≥ 70 latidos por. ivabradine is indicated :in adults unable to tolerate or with a contraindication to the use of beta-blockersor in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. tratamiento de la insuficiencia cardíaca crónica ivabradina está indicada en la insuficiencia cardíaca crónica ii de la nyha de clase iv con disfunción sistólica, en pacientes en ritmo sinusal y cuya frecuencia cardiaca es ≥ 75 bpm, en combinación con la terapia estándar incluyendo tratamiento betabloqueante o cuando tratamiento betabloqueante está contraindicada o no tolerada.

Европска Унија - Шпански - EMA (European Medicines Agency)

eisai gmbh - bexaroteno - linfoma, t-cell, cutáneo - agentes antineoplásicos - las cápsulas de targretin están indicadas para el tratamiento de las manifestaciones cutáneas de los pacientes con linfoma cutáneo de células t en estadio avanzado (ctcl) refractarios a al menos un tratamiento sistémico.

Европска Унија - Шпански - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ombitasvir, paritaprevir, ritonavir - hepatitis c, crónica - antivirales para uso sistémico - viekirax está indicado en combinación con otros medicamentos para el tratamiento de la hepatitis c crónica (chc) en adultos. para el virus de la hepatitis c (vhc) de genotipo específico de la actividad.

Европска Унија - Шпански - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hipertensión, pulmonar - los antihipertensivos,los - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Европска Унија - Шпански - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - artritis, reumatoide - inmunosupresores - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 y 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Европска Унија - Шпански - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - glecaprevir, pibrentasvir - hepatitis c, crónica - antivirales para uso sistémico - maviret is indicated for the treatment of chronic hepatitis c virus (hcv) infection in adults and children aged 3 years and older. maviret coated granules is indicated for the treatment of chronic hepatitis c virus (hcv) infection in children 3 years and older.

Европска Унија - Шпански - EMA (European Medicines Agency)

merck europe b.v. - la cladribina - esclerosis múltiple - inmunosupresores - tratamiento de pacientes adultos con esclerosis múltiple (ms) recidivante altamente activa, tal como se define en las características clínicas o de imagen.

Европска Унија - Шпански - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir, velpatasvir, voxilaprevi - hepatitis c, crónica - antivirales para uso sistémico - vosevi is indicated for the treatment of chronic hepatitis c virus (hcv) infection in patients aged 12 years and older and weighing at least 30 kg. (ver secciones 4. 2, 4. 4 y 5.