Euroopa Liit - horvaadi - EMA (European Medicines Agency)

roche registration gmbh - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - imunosupresivi - esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

pharmaand gmbh - panobinostat laktat bezvodni - multipli mijelom - antineoplastična sredstva - farydak, u kombinaciji s bortezomibom i deksametazon, je indiciran za liječenje odraslih bolesnika s recidivirajućim i/ili refraktornim oblikom multiplog mijeloma koji su primili najmanje dvije prethodne režima uključujući bortezomib i agent imunomodulatorni. farydak, u kombinaciji s bortezomibom i deksametazon, je indiciran za liječenje odraslih bolesnika s recidivirajućim i/ili refraktornim oblikom multiplog mijeloma koji su primili najmanje dvije prethodne režima uključujući bortezomib i agent imunomodulatorni.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

novartis europharm limited - финголимод hidroklorid - multipla skleroza - imunosupresivi - gilenya je navedeno kao jedan bolesti дорабатывая 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 terapije (za iznimke i informacija o вымыванию razdoblja vidi 4. 4 i 5. orpatients 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 opterećenja t2 lezija u odnosu na najnoviji mri.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - poremećaji spavanja, cirkadijski ritam - psycholeptics - hetlioz je indiciran za liječenje ne-24-satnog poremećaja spavanja (ne-24) u potpuno slijepim odraslima.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

takeda pharma a/s - alogliptin, pioglitazone - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - incresync is indicated as a second- or third-line treatment in adult patients aged 18 years and older with type-2 diabetes mellitus: , as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance;, in combination with metformin (i. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod odraslih pacijenata (posebno u pacijenata s viškom težine) neadekvatna na njihovu maksimalnu переносимой doze метформина i пиоглитазона. osim toga , incresync može se koristiti kako bi zamijeniti pojedine tablete alogliptin i pioglitazone u onih odraslih pacijenata u dobi od 18 godina i stariji sa dm-2 već šećerna bolest liječi sa ovom kombinacijom. nakon početka terapije s incresync, pacijenti moraju biti revidiran nakon tri do šest mjeseci, za procjenu adekvatnosti odgovora na liječenje (e. smanjenje pokazatelja hba1c). kod bolesnika koji ne pokazuju adekvatan odgovor, incresync treba prestati. u svjetlu potencijalnih rizika kod duljeg pioglitazone terapija, propisane lijekove treba potvrditi u kasnijim rutinske inspekcije da dobro incresync sprema (vidi odjeljak 4.

Euroopa Liit - horvaadi - 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.

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eisai gmbh - lenvatinib mesilat - karcinom, stanice bubrega - antineoplastična sredstva - kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (rcc):in combination with pembrolizumab, as first-line treatment (see section 5. in combination with everolimus, following one prior vascular endothelial growth factor (vegf)-targeted therapy.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

astrazeneca ab  - метформина hidroklorid, hidroklorid саксаглиптин - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze je indiciran kao dodatak dijeti i tjelovježbi za poboljšanje kontrole glikemije u odraslih bolesnika u dobi od 18 godina i stariji tip-2 šećerne bolesti glikemija podnošljivom dozom samog ili onih već liječeni kombinacijom saksagliptina i metformina kao zasebnih tableta. komboglyze je također indiciran u kombinaciji s inzulina (ja. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod odraslih pacijenata u dobi od 18 godina i stariji tip-2 dijabetesa, kada inzulina i метформина sami ne pružaju adekvatnu glikemijski kontrole.

Euroopa Liit - horvaadi - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilat - neoplazme štitnjače - antineoplastična sredstva - lenvima prikazan kao monoterapija za liječenje odraslih bolesnika s прогрессирующим, lokalno-uobičajena ili metastaze, diferencira (папиллярный/фолликулярный/hürthle staničnog) rak štitnjače (dtc), рефрактерным na konstanta Йоду (rai). lenvima prikazan kao monoterapija za liječenje odraslih bolesnika s preliminarnim ili operirati гепатоцеллюлярной karcinom (hcc), koji su primili ne prije sistemske terapije.