Evropská unie - maďarština - EMA (European Medicines Agency)

dompé biotec s.p.a. - darbepoetin alfa - kidney failure, chronic; anemia; cancer - antianémiás készítmények - krónikus veseelégtelenségben (crf) szenvedő tünetekkel járó anémia kezelése felnőttek és gyermekkorú betegek körében. tünetekkel járó vérszegénység, a felnőtt daganatos betegek nem myeloid rosszindulatú daganatok kemoterápiás kezelés alatt.

Evropská unie - maďarština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterokolitis, pseudomembranous - immunrendszer sera, immunglobulinok, - zinplava javallt a clostridium difficile fertőzés (cdi) előfordulásának megelőzése a felnőttek nagy a kockázata az ismételt cdi.

Evropská unie - maďarština - EMA (European Medicines Agency)

sanofi winthrop industrie - clopidogrel hidrogén-szulfát - stroke; peripheral vascular diseases; atrial fibrillation; myocardial infarction; acute coronary syndrome - antitrombotikus szerek - secondary prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from seven days until less than six months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome:non-st-segment-elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st-segment-elevation acute myocardial infarction, in combination with asa in patients undergoing percutaneous coronary intervention (including patients undergoing a stent replacement) or medically treated patients eligible for thrombolytic/fibrinolytic therapy. in patients with moderate to high-risk transient ischemic attack (tia) or minor ischemic stroke (is)clopidogrel in combination with asa is indicated in:adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event. megelőzés, a atherothrombotic, valamint thromboemboliás események pitvari fibrillationin felnőtt betegek pitvarfibrilláció, akik legalább egy kockázati tényező a vascularis események, vagy nem megfelelő kezelés a k-vitamin antagonisták, akik egy alacsony vérzés kockázatát, a clopidogrel javasolt kombinálva asa a megelőzés, a atherothrombotic, valamint thromboemboliás események, beleértve a stroke.

Evropská unie - maďarština - EMA (European Medicines Agency)

pfizer limited - szunitinibbel - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - daganatellenes szerek - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Evropská unie - maďarština - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Evropská unie - maďarština - EMA (European Medicines Agency)

biogen netherlands b.v. - dimetil-fumarát - szklerózis multiplex - immunszuppresszánsok - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Evropská unie - maďarština - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cisztás fibrózis - egyéb légzőszervi termékek - orkambi tabletta javallott a cisztás fibrózis (cf) a betegek éves 6 éves vagy idősebb, akik homozigóta a f508del mutáció a cftr gén. orkambi granules are indicated for the treatment of cystic fibrosis (cf) in children aged 1 year and older who are homozygous for the f508del mutation in the cftr gene.

Evropská unie - maďarština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, krónikus - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 és 5. a hepatitis c vírus (hcv) genotípus specifikus tevékenység, lásd 4. 4 és 5.

Evropská unie - maďarština - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - arthritis, rheumatoid - immunszuppresszánsok - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). az olumiant monoterápiában vagy metotrexáttal kombinációban alkalmazható. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Evropská unie - maďarština - EMA (European Medicines Agency)

mcm vaccine b.v. - diftéria toxoidot tartalmazza, tetanusz toxoid, bordetella pertussis antigének: pertussis toxoid, rákok fonalas hemagglutinin, pertactin, fimbriae típusú, 2, 3, hepatitis b felületi antigén élesztősejtekben, poliovírus (inaktivált): írja be az 1 (mahoney), írja be a 2 (mef-1), 3-as típusú (saukett) előállított vero sejt/ b-típusú haemophilus influenzae poliszacharid (polyribosylribitol foszfát) konjugált meningococcus fehérje. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - a vakcinák - vaxelis (dtap-hb-ipv-hib) javallt elsődleges és emlékeztető oltás a csecsemők és a kisgyermekek, 6 hetes kortól diftéria, tetanusz, pertussis, hepatitis b, poliomyelitis és invazív betegségek okozta haemophilus influenzae b típus (hib). a vaxelis használatának összhangban kell lennie a hivatalos ajánlásokkal.