Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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 i 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 i 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

esteve pharmaceuticals, s.a. - duloksetin - anxiety disorders; depressive disorder, major; diabetic neuropathies - psychoanaleptics, - liječenje velikog depresivnog poremećaja;liječenje dijabetičke periferne neuropatske boli;liječenje generalizirani anksiozni poremećaj;baikal je navedeno u odraslih.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

chiesi pharmaceuticals gmbh, gonzagagasse 16/16, beč, austrija - fosfolipidna frakcija od svinjskih pluća - ukapna tekućina za dušnik i pluća, suspenzija - 120 mg/1,5 ml - urbroj: 1 bočica od 1,5 ml sadrži 120 mg fosfolipidne frakcije iz svinjskih pluća (poraktant alfa). 1 ml suspenzije: 80 mg/ml fosfolipidne frakcije iz svinjskih pluća (poraktant alfa), što odgovara približno 74 mg/ml ukupnih fosfolipida i 0,9 mg/ml hidrofobnih bjelančevina male molekulske mase

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

chiesi pharmaceuticals gmbh, gonzagagasse 16/16, beč, austrija - fosfolipidna frakcija od svinjskih pluća - ukapna tekućina za dušnik i pluća, suspenzija - 240 mg/3,0 ml - urbroj: 1 bočica od 3,0 ml sadrži 240 mg fosfolipidne frakcije iz svinjskih pluća (poraktant alfa) 1 ml suspenzije: 80 mg/ml fosfolipidne frakcije iz svinjskih pluća (poraktant alfa), što odgovara približno 74 mg/ml ukupnih fosfolipida i 0,9 mg/ml hidrofobnih bjelančevina male molekulske mase

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemija, mieloidna, akutna - antineoplastična sredstva - vyxeos liposomal indiciran za liječenje odraslih bolesnika s je prvi put dijagnosticiran, terapije povezane s oštrim миелоидными лейкозами (t-aml) ili aml s миелодисплазией promjene (aml-МРЦ).

Europska Unija - hrvatski - EMA (European Medicines Agency)

cycle pharmaceuticals (europe) ltd - nitisinone - tyrosinemias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - liječenje i pedijatrijski bolesne odrasle osobe s potvrđene dijagnoze nasljedne тирозинемии 1 (ХТ-1) u kombinaciji s prehrambenim ograničenjima tirozin i fenilalanin.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasirox - iron overload; beta-thalassemia - Željeza chelation - Деферазирокс mylan u naznačeno za liječenje kronične preopterećenje željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u bolesnika s beta-талассемией gradonačelnik u dobi od 6 godina i olderthe liječenje kronične preko-zasićenih željezom zbog трансфузий krvi, kada je terapija дефероксамином kontraindiciran ili неадекватна od sljedećih skupina bolesnika:kod pedijatrijska bolesnika s beta-талассемией s preopterećenje željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u dobi od 2 do 5 godina,u pedijatrijskoj i odraslih pacijenata s beta-талассемией s preopterećenje željezom zbog rijedak transfuziju krvi (.

Europska Unija - hrvatski - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumori gastrointestinalnog stroma - antineoplastična sredstva - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - pripravci za liječenje rana i ulkusa - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.