ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

sanofi b.v. - eliglustat - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - cerdelga je indiciran za dugoročno liječenje odraslih bolesnika s gaucherove bolesti tipa 1 (gd1), koji su cyp2d6 slabih metabolizatora (pms), srednji metabolizatori (ims) ili opsežna metabolizatori (ems).

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

roche registration gmbh - cobimetinib hemifumarata - melanoma - antineoplastična sredstva - cotellic je indiciran za uporabu u kombinaciji s vemurafenibom za liječenje odraslih bolesnika s neresektabilnim ili metastatskim melanomom s mutacijom braf v600.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

basilea pharmaceutica deutschland gmbh - isavuconazole - aspergiloza - cresemba prikazan kod odraslih za liječenje:invazivne aspergillosismucormycosis kod pacijenata, za koje je amfotericin b inappropriateconsideration treba davati službene preporuke za odgovarajuće korištenje antifungalna lijekova.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

mylan pharmaceuticals limited - danmavir - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv-1) infection (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):za liječenje hiv-1 infekcije u антиретровирусной terapije (art)-iskusni odrasli pacijenti, uključujući i one koji su bili jako prethodno obrađene. za liječenje hiv-1 infekcije u pedijatrijska bolesnika u dobi od 3 godina i najmanje 15 kg tjelesne težine. odlučivši započeti liječenje s дарунавир uvedeni zajedno s malom dozom ritonavir, pažljivo razmatranje treba posvetiti povijesti liječenje pacijenta i prirode mutacije povezane s različitim posrednika. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 i 5. Дарунавир uvedeni zajedno s malom dozom ritonavir je navedeno u kombinaciji s drugim антиретровирусными lijekovima za liječenje pacijenata s virusom humane imunodeficijencije (hiv-1 infekcije) .  darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.  darunavir mylan 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (art)-naïve (see section 4.  art-experienced with no darunavir resistance associated mutations (drv-rams) and who have plasma hiv-1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 10⁶/l. odlučivši započeti liječenje s дарунавир u takvim art-iskusan pacijenata, генотипическое testiranje trebali bi se rukovoditi pri korištenju дарунавир (vidi 4. 2, 4. 3, 4. 4 i 5.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

otsuka novel products gmbh - Деламанид - tuberkuloza, višestruko otporna - antimikobakterija - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 i 5. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

alfasigma s.p.a. - piperaquine tetraphosphate, artenimol - malarija - antiprotozoals - eurartesim je indiciran za liječenje nekompliciranog plasmodium falciparum malarije kod odraslih, djece i dojenčadi 6 mjeseci i više i težine 5 kg ili više. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje противомалярийных posrednika.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec is indicated for the treatment of , adult and 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;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric 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-pdgfra rearrangement. učinak Гливека na ishod transplantacije koštane srži još nije određen. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik recidiva ne bi trebali primati adjuvantne terapije; liječenje odraslih bolesnika s метастатической выбухающей dermatofibrosarcoma (dfsp) i odraslih pacijenata s relaps i / ili метастатической dfsp, koji nemaju pravo na operaciju. u odrasle osobe i pedijatrijska bolesnika, učinkovitosti glivec se temelji na zajedničkim гематологических i цитогенетических odgovora i preživljavanja bez progresije kod kml, na гематологический i цитогенетический odgovor cijene na ph+ all, mds / rafinerija, na гематологические indikatori odgovora u hes / cel i objektivnih odgovora kod odraslih pacijenata s неоперабельными i / ili метастатическими gist i dfsp i na безрецидивную stopa preživljavanja pri adjuvantne bit. iskustvo glivec u bolesnika s mds / rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen (vidi odjeljak 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

pfizer europe ma eeig  - palbociclib - neoplazme dojki - antineoplastična sredstva - ibrance indiciran za liječenje hormonalnih receptora (op) je pozitivan, людское эпидермическое ako uređaj primatelja 2 faktor rasta (her2 i) negativne lokalno-uobičajena ili metastatskih tumora dojke:u kombinaciji s inhibitor aromataze, u kombinaciji s fulvestrant kod žena koje su dobili preliminarne hormonsko nadomjesno liječenje. u pre - ili perimenopauzi, endokrini terapija mora biti u kombinaciji s luteinizirajućeg hormona releasing hormon (lhrh) agonist.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

janssen-cilag international n.v. - telaprevir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - incivo, u kombinaciji sa peg interferonom alfa i ribavirinom, indiciran za liječenje genotip 1 kroničnog hepatitisa c kod odraslih pacijenata s компенсированным bolesti jetre (uključujući cirozu):koji je tretman naivan, koji je ranije liječenje interferonom alfa (пегилированным ili пегилированным) kao monoterapija ili u kombinaciji sa ribavirinom, uključujući i recidiv, djelomični okrivljenika i неответчики.

ইউরোপীয় ইউনিয়ন - ক্রোয়েশীয় - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (kao fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastična sredstva - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. Полицитемия vjera (mf)jakavi indiciran za liječenje odraslih bolesnika s полицитемия vjera, koje su otporne na ili netoleranciju hidroksiurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.