União Europeia - português - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - gota - antigout preparações - a krystexxa está indicada para o tratamento de gota debilitante de gota tofácea crônica em pacientes adultos que também podem ter comprometimento articular erosivo e que não conseguiram normalizar o ácido úrico sérico com inibidores de xantina oxidase na dose máxima medicamente apropriada ou para quem esses medicamentos estão contra-indicados.

União Europeia - português - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - leucemia linfoblástica com células precursoras - linfoma - agentes antineoplásicos - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - fibrose cística - outros produtos do sistema respiratório - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 e 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - fibrose cística - outros produtos do sistema respiratório - orkambi comprimidos são indicados para o tratamento da fibrose cística (fc) em pacientes com idade entre 6 anos e mais velhos que são homozigotos para a mutação f508del no gene cftr. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

União Europeia - português - EMA (European Medicines Agency)

allergan pharmaceuticals international ltd - pó de pâncreas - insuficiência pancreática exócrina - digestivos, incl. enzimas - tratamento de substituição de enzimas pancreáticas em insuficiência pancreática exócrina por fibrose cística ou outras condições (e. pancreatite crônica, pós-pancreatectomia ou câncer de pâncreas). enzepi é indicado em lactentes, crianças, adolescentes e adultos.

União Europeia - português - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarreicos, intestinal antiinflamatórios / anti infeccioso agentes - truberzi é indicado em adultos para o tratamento da síndrome do intestino irritável com diarréia (ibs d).

União Europeia - português - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrose cística - outros produtos do sistema respiratório - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

União Europeia - português - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leucemia, mieloide, aguda - agentes antineoplásicos - vyxeos lipossomas é indicado para o tratamento de adultos com recém-diagnosticado, o tratamento relacionadas com a leucemia mieloide aguda (t-aml) ou lma com mielodisplasia alterações relacionadas (aml-mrc).

União Europeia - português - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - diabetes mellitus, tipo 2 - drogas usadas em 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. triplo terapia de combinação), como adjuvante da dieta e exercício em pacientes inadequadamente controlados em sua máxima tolerada, a dose de metformina e uma sulphonylurea. 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.

Portugal - português - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

theramex ireland limited - colecalciferol - cápsula mole - 20000 u.i. - colecalciferol 0.5 mg - colecalciferol - n/a - duração do tratamento: longa duração