Xofigo Europska Unija - hrvatski - EMA (European Medicines Agency)

xofigo

bayer ag - radium (223ra) dichloride - prostatske neoplazme - terapeutski radiofarmaceutski pripravci - xofigo je indiciran za liječenje odraslih osoba s karcinomom prostate otpornih na kastriranje, simptomatskim koštanim metastazama i bez poznatih visceralnih metastaza.

Zynteglo Europska Unija - hrvatski - EMA (European Medicines Agency)

zynteglo

bluebird bio (netherlands) b.v. - Аутологичная Сd34+ stanica obogaćena populaciji, sadrži гемопоэтические matične stanice pretvorene s lentiglobin bb305 лентивирусные vektori, кодирующие beta-kao-t87q-глобина gena - beta-talasemija - other hematological agents - zynteglo indiciran za liječenje bolesnika starijih od 12 godina s трансфузионно-ovisna β талассемии (ТДТ), koji nemaju β0/β0 genotip, za koje гемопоэтических matičnih stanica (gcw) transplantacija primjereno, a ljudskih лейкоцитарного antigena (hla) odgovara recenzije donatora gcw ne postoji.

Cometriq Europska Unija - hrvatski - EMA (European Medicines Agency)

cometriq

ipsen pharma - cabozantinib - neoplazme štitnjače - antineoplastična sredstva - liječenje odraslih bolesnika s progresivnim, neosjetljivim lokalno naprednim ili metastaznim karcinomom medularnog štitnjače.

Kyprolis Europska Unija - hrvatski - EMA (European Medicines Agency)

kyprolis

amgen europe b.v. - carfilzomib - multipli mijelom - antineoplastična sredstva - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Privigen Europska Unija - hrvatski - EMA (European Medicines Agency)

privigen

csl behring gmbh - ljudski normalni imunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imuni serumi i homologna, - hormonske terapije kod odraslih i djece i adolescenata (0-18 godina): primarne imunodeficijencije (pid) sindromi s kršenjem антителообразования;hypogammaglobulinaemia i rekurentne bakterijske infekcije u bolesnika s kroničnim лимфолейкозом, u kojima su preventivni antibiotici nisu pomogli;hypogammaglobulinaemia i рецидивирующих bakterijskih infekcija kod plato faza-nekoliko bolesnika, koji nisu uspjeli odgovoriti na пневмококковой cijepljenja;hypogammaglobulinaemia u bolesnika nakon аллогенной transplantacije hematopoetski organi-transplantacija matičnih stanica (ТГСК);urođeni aids-a s рецидивирующими bakterijske infekcije. Иммуномодуляция kod odraslih, i kod djece i adolescenata (0-18 godina): primarni imunološki trombocitopenija (ihs), u bolesnika s visokim rizikom od krvarenja ili prije operacije za podešavanje broja trombocita u krvi;sindrom Гийена-barre;bolest kawasaki;kronična upalna демиелинизирующая полинейропатия (ХВДП). samo je ograničeno iskustvo s korištenjem intravenski imunoglobulini, kod djece s ХВДП.

Ultomiris Europska Unija - hrvatski - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Vanflyta Europska Unija - hrvatski - EMA (European Medicines Agency)

vanflyta

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.