Europska Unija - hrvatski - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - sugammadex sodium - neuromuskularna blokada - svi ostali terapeutski proizvodi - uklanjanje neuromuskularne blokade izazvane rokoronom ili vekuronomom. 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)

accord healthcare s.l.u. - Толваптан - neprimjereni adh sindrom - diuretici, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropenija - Иммуностимуляторы, - accofil indiciran za smanjenje trajanja нейтропении i frekvencije фебрильной нейтропении kod pacijenata s utvrđenim цитотоксической kemoterapije na maligni tumori (osim kroničnog миелоидного leukemije i миелодиспластических sindromi), kao i za smanjenje trajanja нейтропении pacijenti koji primaju миелоаблативную terapiju s naknadnim transplantacije koštane srži se smatra rizičnim duge teške нейтропении. sigurnost i učinkovitost accofil-a slične su kod odraslih i djece s citotoksičnom kemoterapijom. accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs). kod bolesnika, djece i odraslih s teške urođene, ciklički ili idiopatskom нейтропении apsolutni broj neutrofila (anc) ≤ 0. 5 x 109/l, a u prošlosti teških ili рецидивирующих infekcije, dugoročno uprave accofil ukazuje na povećanje neutrofila i smanjenje učestalosti i trajanja zaraznih događaja. accofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1. 0 x 109/l) u bolesnika s poodmakloj fazi hiv-infekcije za smanjenje rizika od bakterijske infekcije, kada su druge opcije za upravljanje нейтропения zagubljen.

Europska Unija - hrvatski - EMA (European Medicines Agency)

viiv healthcare bv - lamivudin, зидовудин - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastična sredstva - Азацитидин akord indiciran za liječenje odraslih bolesnika koji nemaju pravo na hematopoetski transplantacija matičnih stanica (ТГСК) s:- middleware-2 i visokog rizika миелодиспластические sindroma (mds) prema međunarodnoj prognozu sustav bodovanja (ipss),- kronični миеломоноцитарный leukemije (ХММЛ) s 10-29 % mozgu бластов bez миелопролиферативные poremećaja, akutnog миелоидного leukemije (aml) s 20-30 % бластов i multi-porijeklo displazije, prema podacima svjetske zdravstvene organizacije (who) za klasifikaciju,- aml s >30% бласты koštane srži prema klasifikaciji svjetske zdravstvene organizacije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - финголимод hidroklorid - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivima selektivni imunosupresivima - istaknuo kao jedan bolest модифицирующей terapije kod visoke aktivnosti relapsing ublažavanje multiplom sklerozom za sljedećih skupina odraslih pacijenata i pedijatrijska bolesnika u dobi od 10 godina i stariji:pacijenti sa visokom aktivnošću bolesti, unatoč potpun i adekvatan tretman sa najmanje jednim bolest дорабатывая therapyorpatients s brzo razvija težak relapsing ublažavanje multiplom sklerozom određuje se 2 ili više teških recidiva u roku od jedne godine, s 1 ili više gadolinij revitalizacije lezija na mr mozga ili značajno povećanje u t2 leglo opterećenja u usporedbi s posljednjim mr.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 i 5. 1 za dostupne podatke o različitim kombinacijama).

Europska Unija - hrvatski - EMA (European Medicines Agency)

ferring pharmaceuticals a/s - degarelix - prostatske neoplazme - endokrinska terapija - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

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)

mylan pharmaceuticals limited - pregabalin - anxiety disorders; epilepsy - antiepileptici sredstva, - Нейропатическая painpregabalin mylan u indiciran za liječenje periferne i centralne neuropatske boli u odraslih. epilepsypregabalin mylan u naznačeno kao dodatni terapija u odraslih s парциальными судорогами sa ili bez sekundarne generalizacije. postati generalizirani anksioznosti disorderpregabalin mylan u indiciran za liječenje generalizirani anksiozni poremećaj (gap) kod odraslih.