Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus:it 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. it is indicated in combination with a sulphonylurea (i. trostruki kombinovanu terapiju) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i sulfonilurejom. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - infekcije citomegalovirusa - antivirusni lijekovi za sustavnu uporabu - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antivirusnih lijekova.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - teriflunomide - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - teriflunomide mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 of the smpc for important information on the population for which efficacy has been established).

Europska Unija - hrvatski - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Europska Unija - hrvatski - EMA (European Medicines Agency)

strides pharma (cyprus) limited - teriparatid - osteoporosis; osteoporosis, postmenopausal - homeostaza kalcija - kauliv is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Europska Unija - hrvatski - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - imunosupresivi - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

Europska Unija - hrvatski - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - neuromuskularna blokada - svi ostali terapeutski proizvodi - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ireland limited - Триоксид arsen - leukemija, promyelocytic, akutna - antineoplastična sredstva - Триоксид arsen mylan u indiciran za indukciju remisije i konsolidacije kod odraslih pacijenata s je prvi put dijagnosticiran niski do srednji rizik akutne промиелоцитарной leukemije (ОПЛ) (bijelih krvnih stanica ≤ 10 x 103/Μl) u kombinaciji s trans-ретиноевая kiselina (ПТРК)- relaps/vatrostalne akutne промиелоцитарной leukemije (ОПЛ) (prethodni tretman treba da sadrže retinoid i kemoterapije), karakterizira t(15;17) translokacije i/ili dostupnost промиелоцитарный leukemije/ретиноевая kiselina receptora alfa (od pml/rar alfa) gena. brzina reakcije druge akutne mijeloične podtipovi leukemije do триоксида arsen ne beenexamined.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare b.v. - долутегравир natrija, рилпивирин hidroklorid - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - juluca indiciran za liječenje virusa humane imunodeficijencije tipa 1 (hiv-1) infekcije kod odraslih, koji вирусологически.-potisnuta (hiv-1 rna.