Európai Unió - magyar - EMA (European Medicines Agency)

eli lilly nederland b.v. - ramucirumab - gyomor-daganatok - daganatellenes szerek - gyomor cancercyramza paclitaxel együtt jelzi kezelésére felnőtt betegek előrehaladott gyomorrák vagy gastro-oesophagealis junction adenocarcinoma a betegség progresszióját után előzetes platina, majd fluoropirimidin kemoterápia. cyramza monoterápia kezelésére felnőtt betegek előrehaladott gyomorrák vagy gastro-oesophagealis junction adenocarcinoma a betegség progresszióját után előzetes platina vagy fluoropirimidin kemoterápia, akiknél a kezelést kombinálva a paklitaxel nem megfelelő. colorectalis cancercyramza, kombinálva folfiri (irinotecan, folinic sav, illetve az 5‑fluorouracil) javallott a felnőtt betegek kezelésére metasztatikus colorectalis rák (mcrc) a betegség progresszióját-jén vagy azt követően előzetes kezelés, bevacizumab, oxaliplatin, valamint egy fluoropirimidin. nem-kissejtes tüdőrák cancercyramza kombinálva docetaxel javallt a felnőtt betegek kezelésére, lokálisan előrehaladott vagy áttétes nem-kissejtes tüdőrák a betegség progresszióját után platina-alapú kemoterápiához. hepatocellularis carcinomacyramza monoterápia kezelésére felnőtt betegek előrehaladott, inoperábilis vagy hepatocellularis carcinoma, akik a szérum alfa-fetoprotein (afp) ≥ 400 ng/ml, akik már korábban kezelt szorafenib.

Európai Unió - magyar - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - szelektív immunszuppresszánsok - 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.

Európai Unió - magyar - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - mellnövekedés - daganatellenes szerek - 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.