Európai Unió - magyar - EMA (European Medicines Agency)

xbiotech germany gmbh - humán igg1 monoklonális antitest, amely humán interleukin-1 alfa-specifikus - colorectalis daganatok - daganatellenes szerek - kezelés a metasztatikus colorectalis rák.

Európai Unió - magyar - EMA (European Medicines Agency)

instituto grifols s.a. - a humán normál immunglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immunrendszer sera, immunglobulinok, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Európai Unió - magyar - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunszuppresszánsok - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

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.

Európai Unió - magyar - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - a sclerosis multiplex, a relapszáló-remittáló - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Magyarország - magyar - OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézetről)

glaxosmithkline biologicals s.a. - vakcina (virális) -

Magyarország - magyar - OGYÉI (Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézetről)

glaxosmithkline biologicals s.a. - vakcina (virális) -

Európai Unió - magyar - EMA (European Medicines Agency)

csl behring gmbh - humán normál immunglobulin (scig) - immunológiai fogyatékossági szindrómák - immunrendszer sera, immunglobulinok, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Európai Unió - magyar - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - daganatellenes szerek - rituzena javallt felnőtteknél a következő jelöléseket:non-hodgkin limfóma (nhl)rituzena kezelésére javallt, a korábban nem kezelt betegek színpad iii iv follicularis lymphoma kemoterápiával kombinálva. rituzena monoterápia a kezelés a betegek színpad iii iv follicularis lymphoma, akik kemoterápiára rezisztens, vagy a második, vagy az azt követő visszaesés után a kemoterápia. rituzena jelzi a kezelés a betegek cd20 pozitív diffúz nagy b-sejtes non-hodgkin lymphoma kombinálva chop (ciklofoszfamid, doxorubicin, vinkrisztin, prednizolon) kemoterápia,. a krónikus limfoid leukémia (cll)rituzena kemoterápiával kombinálva javasolt a kezelés a betegek korábban nem kezelt, valamint visszaesett/tűzálló cll. csak korlátozott adatok állnak rendelkezésre a biztonságosság a betegek korábban kezelt monoklonális antitestek beleértve rituzenaor betegek tűzálló, hogy előző rituzena plusz kemoterápia. féle granulomatosis a polyangiitis, mikroszkopikus polyangiitisrituzena, kombinálva glükokortikoidok javallott az indukciós remisszió felnőtt betegeknél, akiknek súlyos, aktív féle granulomatosis a polyangiitis (wegener) (gpa), valamint a mikroszkopikus polyangiitis (mpa).