Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - agenti za dermatitis, isključujući kortikosteroide - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - febuxostat - hyperuricemia; arthritis, gouty; gout - antigadni pripravci - febuxostat mylan je indiciran za prevenciju i liječenje hiperuricemija u odraslih bolesnika podvrgnutih kemoterapijom zbog zloćudne hematološke bolesti u srednje do visoke opasnosti od tumora lize sindrom (tls). Фебуксостат mylan u indiciran za liječenje kronične hiperurikemijom u uvjetima kada уратные naslage već došlo (uključujući i osobnu povijest, ili dostupnost, отложении soli i/ili nadut artritisa). Фебуксостат mylan u indiciran za odrasle.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

novartis europharm limited - ribociklib sukcinata - neoplazme dojki - antineoplastična sredstva - kisqali je indiciran za liječenje žena s hormon receptor (h)‑pozitivan, людское эпидермическое ako uređaj primatelja 2 faktor rasta (her2)‑negativan lokalno-uobičajena ili metastatskih tumora dojke u kombinaciji s inhibitor aromataze, ili fulvestrant kao izvor endokrine terapije na temelju ili u žene koje su primili do hormonske terapije. u pre‑ ili perimenopauzi, endokrini terapija mora biti u kombinaciji s luteinizirajućeg hormona releasing hormon (lhrh) agonist.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

accord healthcare s.l.u. - lakozamida - epilepsija - antiepileptici sredstva, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

gen.orph - miglustat - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - miglustat gen. orph je indiciran za oralno liječenje odraslih pacijenata s blagom do umjerenom bolesti tipa 1 gaucher. miglustat generacije. k. orf može se koristiti samo u liječenju pacijenata za koje je ферментозаместительная terapija ne odgovara. miglustat gen. orph-to je indiciran za liječenje neuroloških poremećaja kod odraslih pacijenata i pedijatrijska bolesnika s bolesti Ниманна-vrhunac tip s .

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

novartis europharm ltd - midostaurin - leukemia, myeloid, acute; mastocytosis - antineoplastična sredstva - rydapt glasi:u kombinaciji sa standardnim daunorubicin i цитарабин indukcije i visoke doze цитарабина konsolidacije kemoterapije i pacijenata na potpun odgovor je uslijedio rydapt jedan agent podržava terapija za odrasle pacijente s je prvi put dijagnosticiran oštrim миелоидным лейкозом (aml), koji su mutacije flt3 po pozitivnim (vidi odjeljak 4. 2);u monoterapiji za liječenje odraslih bolesnika s agresivni sustavne mastocytosis (afm), i sustavne mastocytosis s popratnim гематологическими новообразованиями (cm en), ili pretilih stanica leukemije (Μl).

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

janssen-cilag international nv - дарунавир, кобицистат, эмтрицитабин, Тенофовир alafenamide - hiv infekcije - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - symtuza je indiciran za liječenje humane imunodeficijencije tip 1 (hiv‑1) infekcija u odraslih i adolescenata (u dobi od 12 godina i stariji sa tijela težina najmanje 40 kg). genotypic testing should guide the use of symtuza.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

serb sas - telotristat etiprat - carcinoid tumor; neuroendocrine tumors - ostali prehrambeni proizvodi i proizvodi metabolizma - xermelo je indiciran za liječenje dijareje karcinoidnih sindroma u kombinaciji s terapijom somatostatinskog analoga (ssa) u odraslih koji su nedovoljno kontrolirani ssa terapijom.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

mylan pharmaceuticals limited - anagrelide hidroklorid - trombocitemija, esencijalna - antineoplastična sredstva - anagrelide indiciran za snižavanje povišene trombocite u uz značajan thrombocythaemia rizika (fl) pacijenata koji su netolerantni na njihove trenutne terapije ili kod kojih je podignuta razina trombocita pada na prihvatljivu razinu njihove trenutne terapije. an at-risk patientan at-risk essential thrombocythaemia patient is defined by one or more of the following features:>60 years of age ora platelet count >1,000 x 10⁹/l ora history of thrombo-haemorrhagic events.

Den Europæiske Union - kroatisk - EMA (European Medicines Agency)

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic acid, metformin hydrochloride - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:in patients not adequately controlled on their maximally tolerated dose of metformin alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin patients already being treated with the combination of ertugliflozin and metformin as separate tablets.