Európska únia - slovenčina - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - dna - antiguty prípravky - liek krystexxa je indikovaný na liečbu ťažkou slabnúcej chronickej uzlovitou dospelých pacientov, ktorí majú aj erozívna spoločné zapojenie a ktorí zlyhali k normalizácii sérovej kyseliny močovej s inhibítory xantínoxidázy max.12 medicínsky primerané dávky alebo pre ktorých sú tieto lieky kontraindikované.

Európska únia - slovenčina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - kyselina zoledrónová - zlomeniny, kosti - lieky na liečbu chorôb kostí - prevencia kostry súvisiacich udalostí (patologické fraktúry, chrbtice, tlaku, žiarenie alebo chirurgického zákroku na kosti, alebo nádor vyvolaných hypercalcaemia) u dospelých pacientov s pokročilým malignancies zahŕňajú kosti;liečbu dospelých pacientov s nádor vyvolaných hypercalcaemia (tih).

Európska únia - slovenčina - EMA (European Medicines Agency)

nova laboratories ireland limited - 6-merkaptopurín monohydrát - leukémia, lymfóza - antineoplastické činidlá - xaluprin je indikovaný na liečbu akútnej lymfoblastickej leukémie (all) u dospelých, dospievajúcich a detí.

Európska únia - slovenčina - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dyslipidémia - Činidlá modifikujúce lipidy - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Európska únia - slovenčina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - 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 a 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 a 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

allergan pharmaceuticals international limited - eluxadoline - irritable bowel syndrome; diarrhea - antidiarrheals, črevné protizápalové / antiinfective agentov - truberzi je indikovaný u dospelých na liečbu syndrómu dráždivého čreva s hnačkou (ibs d).

Európska únia - slovenčina - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - hydrokortizon - adrenálna nedostatočnosť - kortikosteroidy na systémové použitie - liečba adrenálnej insuficiencie u dospelých.

Európska únia - slovenčina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - orkambi tablety sú uvedené pre liečbu cystickej fibrózy (cf) u pacientov vo veku 6 rokov a starších, ktorí sú homozygous pre f508del mutácie v cftr géne. 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.

Európska únia - slovenčina - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - všetky ostatné terapeutické produkty - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Európska únia - slovenčina - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - ostatné antiepileptiká - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.