Vyvgart Európai Unió - magyar - EMA (European Medicines Agency)

vyvgart

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.

Vydura Európai Unió - magyar - EMA (European Medicines Agency)

vydura

pfizer europe ma eeig  - rimegepant - migrénes betegségek - antimigraine preparations, calcitonin gene-related peptide (cgrp) antagonists - vydura is indicated for theacute treatment of migraine with or without aura in adults;preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Soliris Európai Unió - magyar - EMA (European Medicines Agency)

soliris

alexion europe sas - ekulizumab - hemoglobinuria, paroxysmal - immunszuppresszánsok - soliris-kezelés javallt gyermekek kezelésére:paroxizmális éjjeli haemoglobinuria (pnh). bizonyíték a klinikai haszon kimutatható a betegek hemolízis klinikai tünet(ek) jelzi, hogy a magas betegség tevékenység, függetlenül attól, transzfúzió történelem (lásd 5. atipikus hemolitikus urémiás szindróma (ahus). soliris-kezelés javallt felnőtteknél a kezelést:tűzálló generalizált myasthenia gravis (gmg) a betegek, akik anti-acetilkolin receptor (achr) antitest-pozitív (lásd 5. neuromyelitis optica spektrum zavar (nmosd) a betegek, akik anti-aquaporin-4 (aqp4) antitest-pozitív egy lappangó betegség lefolyása.

Ultomiris Európai Unió - magyar - EMA (European Medicines Agency)

ultomiris

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.

Jayempi Európai Unió - magyar - EMA (European Medicines Agency)

jayempi

nova laboratories ireland limited - azatioprin - graft visszautasítás - immunszuppresszánsok - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Buccolam Európai Unió - magyar - EMA (European Medicines Agency)

buccolam

neuraxpharm pharmaceuticals s.l. - midazolam - epilepszia - pszicholeptikumok - hosszantartó, akut, görcsös görcsök kezelése csecsemőknél, kisgyermekeknél, gyermekeknél és serdülőknél (3 hónapos és 18 évnél rövidebb idő alatt). buccolam csak akkor kell használni, a szülők / gondozók, ahol a beteg már diagnosztizált, hogy epilepsziás. a csecsemők között három-hat hónapos korban, a kezelést a kórházban, ahol megfigyelésre van lehetőség, újraélesztéshez szükséges berendezések rendelkezésre állnak.

Emselex Európai Unió - magyar - EMA (European Medicines Agency)

emselex

pharmaand gmbh - darifenacin-hidrobromid - urinary incontinence, urge; urinary bladder, overactive - urologicals, gyógyszerek, a vizelet inkontinencia gyakorisága, - a sürgősségi inkontinencia és / vagy a gyakoribb sürgősségű vizeletürítés tüneti kezelése felnőtt pácienseknél, akiknél hiperaktív húgyhólyag-szindróma fordult elő.

Sonata Európai Unió - magyar - EMA (European Medicines Agency)

sonata

meda ab - zaleplon - alvási beavatkozás és karbantartás - pszicholeptikumok - a sonata olyan álmatlanságban szenvedő betegek kezelésére javallt, akiknél alváshiány merül fel. ez csak akkor jelezhető, ha a rendellenesség súlyos, letiltja vagy az egyént rendkívüli szorongásnak teszi ki.