Uni Eropa - Hungaria - EMA (European Medicines Agency)

bial - portela & ca, s.a. - eslicarbazepin-acetát - epilepszia - antiepileptikumok, - a zebinix felnőttek, serdülők és 6 évesnél idősebb gyermekek kiegészítő terápiájára utal, részleges rohamokkal, másodlagos generalizációval vagy anélkül.

Uni Eropa - Hungaria - 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.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

gennisium pharma - a koffein-citrát - apnoe - psychoanaleptics, - a kezelés elsődleges apnoe korai újszülöttek.

Uni Eropa - Hungaria - 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.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukémia, 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.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

bial - portela cª, s.a. - opicapone - parkinson kór - parkinson-ellenes szerek - ongentys szerepel, mint kiegészítő terápia a levodopa készítmények / felnőtt betegek parkinson-kór és a végén az adag-a motor ingadozások aki nem stabilizálódik a kombinációira dopa dekarboxiláz-gátlók (ddci). ongentys szerepel, mint kiegészítő terápia a levodopa készítmények / felnőtt betegek parkinson-kór és a végén az adag-a motor ingadozások aki nem stabilizálódik a kombinációira dopa dekarboxiláz-gátlók (ddci).

Uni Eropa - Hungaria - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - a naloxon-hidroklorid-dihidrát - opioidhoz kapcsolódó rendellenességek - minden más terápiás készítmény - a nyxoid azonnali beadásra szolgál az ismert vagy feltételezett opioid túladagolás sürgősségi terápiájánál, melyet légzési és / vagy központi idegrendszeri depresszió jelent, mind a nem orvosi, mind az egészségügyi ellátásban. nyxoid is indicated in adults and adolescents aged 14 years and over. nyxoid is not a substitute for emergency medical care.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrasztim - neutropenia - immunostimulants, - csökkenti a neutropenia időtartamát, valamint az előfordulási gyakorisága a lázas neutropenia, kemoterápia miatt.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

mundipharma corporation (ireland) limited - pegfilgrasztim - neutropenia - immunostimulants, - neutropenia és az előfordulási gyakorisága a felnőtt betegek lázas neutropenia időtartamának csökkentése a malignitás (kivéve a krónikus myeloid leukémia, és myelodysplasiás szindrómák) citotoxikus kemoterápiával kezelt.

Uni Eropa - Hungaria - EMA (European Medicines Agency)

norgine b.v. - vasmaltol - anémia, vas-hiány - antianémiás készítmények - feraccru javallt felnőtteknél a kezelést a vashiányos.