Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

mallinckrodt pharmaceuticals ireland limited - žmogaus fibrinogenas, žmogaus trombinas - hemostasas, chirurginis - antihemoraginiai - palaikomasis gydymas, kai chirurgijoje nepakanka standartinių chirurginių metodų. raplixa turi būti naudojama kartu su patvirtintu želatina kempinė. raplixa yra nurodyta suaugusiesiems nuo 18 metų amžiaus.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticazė - podagra - antigout preparatai - krystexxa skirtas gydyti sunkia sekinančia lėtine tofusine podagra suaugusiems pacientams, kurie taip pat gali turėti erozinis sąnarių pažeidimais ir kuriems nepavyko normalizuoti kraujo serume šlapimo rūgšties ksantino oksidazės inhibitoriais didžiausias mediciniškai tinkama dozė arba kuriems negalima skirti šie vaistai.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dislipidemijos - lipidą keičiančios medžiagos - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekursorių ląstelių limfoblastinė leukemija-limfoma - antinavikiniai vaistai - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivakaftoras - cistinė fibrozė - kiti kvėpavimo sistemos produktai - 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 ir 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 ir 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistinė fibrozė - kiti kvėpavimo sistemos produktai - orkambi tabletės yra nurodyta gydyti cistine fibroze (cf) pacientams nuo 6 metų ir vyresni, kurie yra homozigotiniam už f508del mutacija cftr geno. 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistinė fibrozė - kiti kvėpavimo sistemos produktai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - cannabidiol - lennox gastaut syndrome; epilepsies, myoclonic - antiepileptics, - epidyolex yra nurodyta naudoti kaip adjunctive terapijos priepuolių, susijusių su lennox gastaut sindromas (lgs) arba dravet sindromas (ds), kartu su klobazamas, pacientams, 2 metų amžiaus ir vyresni.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistinė fibrozė - kiti kvėpavimo sistemos produktai - 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.

Europos Sąjunga - lietuvių - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukemija, mieloidas, ūmus - antinavikiniai vaistai - vyxeos liposomal fluorouracilu ir folino suaugusiųjų su naujai diagnozuota, terapijos susijusių ūminės mieloidinės leukemijos (t-ppp) arba pinigų plovimo su myelodysplasia susiję pokyčiai (aml-mrc).