Európska únia - slovenčina - EMA (European Medicines Agency)

glaxosmithkline trading services - mepolizumab - astma - drogy obštrukčnej choroby dýchacích ciest, - severe eosinophilic asthmanucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. chronic rhinosinusitis with nasal polyps (crswnp)nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. eosinophilic granulomatosis with polyangiitis (egpa)nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (egpa). hypereosinophilic syndrome (hes)nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Európska únia - slovenčina - EMA (European Medicines Agency)

genzyme europe bv - sevelamer hydrochlorid - hyperphosphatemia; renal dialysis - všetky ostatné terapeutické produkty - tasermity je indikovaná na kontrolu hyperfosfatémie u dospelých pacientov, ktorí dostávajú hemodialýzu alebo peritoneálnu dialýzu. sevelamer hydrochloridom užívať v kontexte kombinovaného terapeutického postupu, ktorý by mohol zahŕňať vápnika, 1,25 dihydroxy vitamín d3 alebo niektorý z jeho analógov na kontrolu vývoja renálnej kostnej choroby.

Európska únia - slovenčina - EMA (European Medicines Agency)

eli lilly nederland b.v. - drotrekogín alfa (aktivovaný) - sepsis; multiple organ failure - antitrombotické činidlá - xigris je indikovaný na liečbu dospelých pacientov s ťažkou sepsou s viacnásobným zlyhávaním orgánov, ak sa pridávajú do najlepšej štandardnej starostlivosti. použitie lieku xigris sa má zvážiť hlavne v situáciách, kedy môže byť liečba zahájená do 24 hodín po nástupe poruchy orgánu (ďalšie informácie nájdete v časti 5.

Európska únia - slovenčina - EMA (European Medicines Agency)

cis bio international - yttrium (90y) chloride - radionuklidové zobrazovanie - diagnostické rádiofarmaká - používať len na rádioaktívne značenie nosičových molekúl, ktoré boli špecificky vyvinuté a povolené na rádioaktívne značenie týmto rádioaktúlidom. radiopharmaceutical precursor - not intended for direct application to patients.

Európska únia - slovenčina - EMA (European Medicines Agency)

intervet international b.v. - fluralaner - ectoparaciticides, insekticídy a repelenty - kura - liečba napadnutia hydiny z červeného roztoča (dermanyssus gallinae) u nosníc, chovateľov a nosníc.

Európska únia - slovenčina - EMA (European Medicines Agency)

intervet international b.v. - bunka spojená s live rekombinantnej turecko herpesvirus (kmeň hvp360), vyjadriť syntézy bielkovín z nÁjsŤ vírus a vp2 bielkovín ibd vírus - herpes vírus vtáčej (marek choroba) + vtáčej infekčné bursal disease virus (gumboro choroba) + newcastle disease virus/paramyxovirus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

Európska únia - slovenčina - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - liečivá na dermatitídu okrem kortikosteroidov - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

dany bienenwohl gmbh - šťavelovej disodný - ectoparasiticides pre topické použitie, vrátane dph. insekticídy - včely - na liečbu varroosis (varroa destructor) medu včely (apis mellifera) v mláďat-free kolónie.

Európska únia - slovenčina - EMA (European Medicines Agency)

dany bienenwohl gmbh - šťavelovej disodný - ectoparasiticides for topical use, incl. insecticides, ectoparaciticides, insecticides and repellents - honey bees - na liečbu varroosis (varroa destructor) medu včely (apis mellifera) v mláďat-free kolónie.

Európska únia - slovenčina - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinúria, paroxysmálna - selektívne imunosupresíva - 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.