Evropska unija - slovenščina - EMA (European Medicines Agency)

provepharm sas - metiltioninijev klorid - methemoglobinemija - vsi drugi terapevtski izdelki - akutna simptomatska obravnava methemoglobinemije, povzročene z zdravili in kemičnimi proizvodi. methylthioninium chloride proveblue je navedeno pri odraslih, otrocih in mladostnikih (starih od 0 do 17 let).

Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurija, paroksizmal - selektivni imunosupresivi - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

serb sas - telotristat etiprat - carcinoid tumor; neuroendocrine tumors - drugi proizvodi prebavnega trakta in metabolizma - xermelo je indicirano za zdravljenje driska sindrom karcinoid v kombinaciji z somatostatina analogne (ssa) terapija pri odraslih, neustrezno nadzira prp terapijo.

Evropska unija - slovenščina - EMA (European Medicines Agency)

orphelia pharma sas - vigabatrin - spasms, infantile; epilepsies, partial - antiepileptics, - kigabeq je navedeno pri dojenčkih in otrocih od 1 meseca do manj kot 7 leta starosti za:zdravljenje v monotherapy infantilne krči (west sindrom). zdravljenje v kombinaciji z drugimi antiepileptiki zdravil pri bolnikih z odporno delno epilepsijo (osrednja nastop zasegov) z ali brez sekundarne posplošitev, da je, če vse drugo ustrezno zdravilo kombinacije so se izkazali kot neprimerni ali niso bili prenaša.

Evropska unija - slovenščina - EMA (European Medicines Agency)

serb sas - glucarpidase - metabolic side effects of drugs and substances - vsi drugi terapevtski izdelki - voraxaze is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Evropska unija - slovenščina - EMA (European Medicines Agency)

alexion europe sas - asfotaza alfa - hipofosfatazija - drugi zdravljene bolezni prebavil in presnove izdelki, - strensiq je indicirano za dolgotrajno encimska nadomestna terapija pri bolnikih s pediatrijo nastopom hypophosphatasia za zdravljenje kosti manifestacije bolezni.

Evropska unija - slovenščina - EMA (European Medicines Agency)

orphelia pharma sas - klofarabin - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - zdravljenje akutno limfoblastno levkemijo, (vse), pri pediatričnih bolnikih, ki so ponovila ali so ognjevarni po prejemu vsaj dve predhodni režimi in če ni druge možnosti zdravljenja, predvidene za posledico trajno odgovor. varnost in učinkovitost sta bili ocenjeni pri študijah pri bolnikih ≤ 21 let pri začetni diagnozi.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

mylan medical sas - fenofibrat - kapsula, trda - fenofibrat 250 mg / 1 kapsula - fenofibrat

Evropska unija - slovenščina - EMA (European Medicines Agency)

csl behring gmbh - humani normalni imunoglobulin (scig) - sindromi imunološke pomanjkljivosti - imunski sera in imunoglobulini, - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ceva santé animale - cabergoline - prolactine inhibitorji, genito sečil in spolnih hormonov, drugih gynecologicals - za uporabo v čredi program upravljanja krav molznic kot pomoč pri nenadnem sušenje-off z zmanjšanjem proizvodnje mleka:zmanjša uhajanje mleka na sušenje off;zmanjšanje tveganja novih intramammary okužb med suho dobo, zmanjša nelagodje.