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

cyramza

eli lilly nederland b.v. - ramucirumab - neoplazme želuca - antineoplastična sredstva - cancercyramza želuca u kombinaciji s paklitaksel je indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводная аденокарцинома veze s napredovanje bolesti nakon prethodnog platine i fluoropyrimidine kemoterapije. cyramza монотерапия indiciran za liječenje odraslih bolesnika s rakom želuca ili gastro-пищеводный razdvajanje аденокарцинома s napredovanje bolesti nakon prethodnog platine ili fluoropyrimidine kemoterapije, za koje je terapija u kombinaciji s паклитакселом ne odgovara. cancercyramza debelog crijeva, u kombinaciji s folfiri (иринотекан, фолиновой kiselina i 5‑fluorouracil), indiciran za liječenje odraslih bolesnika s metastaze колоректальным raka (mcrc) s napredovanje bolesti tijekom ili nakon prethodne terapije бевацизумабом, Оксалиплатин i fluoropyrimidine. non-mali cancercyramza pluća stanice u kombinaciju sa docetaxel indiciran za liječenje odraslih bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća s napredovanje bolesti nakon kemoterapije платиносодержащей. Гепатоцеллюлярная carcinomacyramza монотерапия indiciran za liječenje odraslih bolesnika s preliminarnim ili operirati гепатоцеллюлярной karcinom, koji imaju u serumu, alfa-фетопротеина (АФП) iznosi ≥ 400 ng/ml, a koje su prethodno liječenih Сорафениб.

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

enhertu

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazme dojki - antineoplastična sredstva - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

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.

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

byooviz

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - ophthalmologicals - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

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

ximluci

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - ophthalmologicals - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

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

ranivisio

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - ophthalmologicals - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).