Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastična sredstva - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, ne-malih stanica pluća - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - Сапроптерин дигидрохлорид - phenylketonurias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - daclatasvir dihydrochloride - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - daklinza je indiciran u kombinaciji s drugim lijekovima za liječenje infekcije kroničnog hepatitisa c (hcv) kod odraslih (vidi odjeljke 4. 2, 4. 4 i 5. za specifične aktivnosti genotip hcv, vidi 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, nasljedni - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Europska Unija - hrvatski - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemija, mieloid - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratoires delbert - histamin дигидрохлорид - leukemija, mieloidna, akutna - Иммуностимуляторы, - ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (il-2). učinkovitost ceplena nije u potpunosti dokazana u bolesnika starijih od 60 godina.

Europska Unija - hrvatski - EMA (European Medicines Agency)

biomarin international limited - Сапроптерин дигидрохлорид - phenylketonurias - drugi gastrointestinalni trakt i metabolizam, lijekovi, - slika je indicirana za liječenje hiperfenilalaninemije (hpa) u odraslih i pedijatrijskih bolesnika svih dobnih skupina s fenilketonurijom (pku) za koje je pokazano da reagiraju na takav tretman. Кувинский je također indiciran za liječenje hyperphenylalaninaemia (hpa) u odraslih i pedijatrijski pacijenti svih uzrasta s tetrahydrobiopterin (СҺ4) nedostatak, koji su pokazali da će odgovoriti na takav tretman.

Europska Unija - hrvatski - EMA (European Medicines Agency)

univar solutions bv - триентин дигидрохлорид - hepatolenticularna degeneracija - drugi gastrointestinalni trakt i metabolizam, lijekovi, - cufence indiciran za liječenje bolesti wilsona u bolesnika s laktoza d-пеницилламин terapije kod odraslih i djece u dobi od 5 i više godina.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan ireland limited - sitagliptin hydrochloride monohydrate, metformin hydrochloride - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - 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. trostruki kombinovanu terapiju) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i sulfonilurejom. 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.