Inrebic Європейський Союз - естонська - EMA (European Medicines Agency)

inrebic

bristol myers squibb pharma eeig - fedratinib dihydrochloride monohydrate - myeloproliferative disorders; primary myelofibrosis - antineoplastilised ained - inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are janus associated kinase (jak) inhibitor naïve or have been treated with ruxolitinib.

Jakavi Європейський Союз - естонська - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruxolitiniib (fosfaadina) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastilised ained - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (pv)jakavi on näidustatud ravi täiskasvanud patsientidel, kellel polycythaemia vera, kes on resistentsed või sallimatu hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Kalydeco Європейський Союз - естонська - EMA (European Medicines Agency)

kalydeco

vertex pharmaceuticals (ireland) limited - ivakaftoor - tsüstiline fibroos - muud hingamisteede tooted - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t. in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5. kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4. 4 ja 5. in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Symkevi Європейський Союз - естонська - EMA (European Medicines Agency)

symkevi

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - tsüstiline fibroos - muud hingamisteede tooted - symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.

Kaftrio Європейський Союз - естонська - EMA (European Medicines Agency)

kaftrio

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - tsüstiline fibroos - muud hingamisteede tooted - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Cayston Європейський Союз - естонська - EMA (European Medicines Agency)

cayston

gilead sciences ireland uc - astreonaami lüsiin - cystic fibrosis; respiratory tract infections - antibacterials süsteemseks kasutamiseks, - cayston on näidustatud pseudomonas aeruginosa põhjustatud krooniliste kopsuinfektsioonide surpressava raviks 6-aastastel ja vanematel tsüstilise fibroosi (cf) patsientidel. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

Tobi Podhaler Європейський Союз - естонська - EMA (European Medicines Agency)

tobi podhaler

viatris healthcare limited - tobramycin - cystic fibrosis; respiratory tract infections - antibacterials süsteemseks kasutamiseks, - tobi podhaler on näidustatud kroonilise pulmonaalse infektsiooni tõttu fibroosiga täiskasvanutel ja 6-aastastel lastel pärssivat ravi tsüstilise fibroosiga. vt lõigud 4. 4 ja 5. 1 andmete kohta erinevates vanuserühmades. tuleks arvesse võtta ametlikke juhiseid sobiva kasutada antibakteriaalseid aineid.

Zeffix Європейський Союз - естонська - EMA (European Medicines Agency)

zeffix

glaxosmithkline (ireland) limited - lamivudiin - b-hepatiit, krooniline - viirusevastased ravimid süsteemseks kasutamiseks - zeffix is indicated for the treatment of chronic hepatitis b in adults with: , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (alt) levels and histological evidence of active liver inflammation and / or fibrosis. algatamise lamivudine ravi tuleks kaaluda ainult juhul, kui kasutada alternatiivset viirusevastane esindaja suurem geneetiline barjäär ei ole kättesaadav või kui see on asjakohane;, dekompenseeritud maksahaigus koos teise agent ilma ristresistentsus lamivudine.

Ofev Європейський Союз - естонська - EMA (European Medicines Agency)

ofev

boehringer ingelheim international gmbh - nintedanib - idiopaatiline kopsufibroos - antineoplastilised ained - ofev on näidustatud täiskasvanutel idiopaatilise kopsufibroosi (ipf).

Vargatef Європейський Союз - естонська - EMA (European Medicines Agency)

vargatef

boehringer ingelheim international gmbh - nintedanib - kartsinoom, mitteväikerakk-kopsu - antineoplastilised ained - vargatefil on näidustatud koos dotsetakseeliga lokaalselt levinud, metastaatilise või lokaalselt retsidiveerunud mitteväikerakk-kopsuvähiga (nsclc) täiskasvanud patsientide raviks, kasvaja lpatsientidest pärast esimese rea keemiaravi.