Jakavi Unia Europejska - polski - EMA (European Medicines Agency)

jakavi

novartis europharm limited - ruksolitynib (w postaci fosforanu) - myeloproliferative disorders; polycythemia vera; graft vs host disease - Środki przeciwnowotworowe - 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. policitemia wiara (pv)jakavi jest wskazany do leczenia dorosłych pacjentów z policitemia wiara, które są odporne na lub nietolerancja гидроксимочевины. 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 Unia Europejska - polski - EMA (European Medicines Agency)

kalydeco

vertex pharmaceuticals (ireland) limited - iwakaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - 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 i 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 i 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.

Orkambi Unia Europejska - polski - EMA (European Medicines Agency)

orkambi

vertex pharmaceuticals (ireland) limited - kombinaci lumacaftor, ivacaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - tabletki orkambi są wskazane w leczeniu mukowiscydozy (cf) u pacjentów w wieku 6 lat i starszych, które są гомозиготами mutacji f508del w genie cftr . 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.

Symkevi Unia Europejska - polski - EMA (European Medicines Agency)

symkevi

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - 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 Unia Europejska - polski - EMA (European Medicines Agency)

kaftrio

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - zwłóknienie torbielowate - inne produkty układu oddechowego - 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.

Ofev Unia Europejska - polski - EMA (European Medicines Agency)

ofev

boehringer ingelheim international gmbh - nintedanib - idiopatyczne włóknienie płuc - Środki przeciwnowotworowe - produkt ofev jest wskazany u dorosłych w leczeniu idiopatycznej fibrozy płuc (ipf).

Tobi Podhaler Unia Europejska - polski - EMA (European Medicines Agency)

tobi podhaler

viatris healthcare limited - tobramycyna - cystic fibrosis; respiratory tract infections - Środki antybakteryjne do stosowania systemowego, - tobi podhaler jest wskazany w leczeniu tłumienia przewlekłego zakażenia płuc wywołanego przez pseudomonas aeruginosa u dorosłych i dzieci w wieku 6 lat i starszych z mukowiscydozą. zobacz rozdziały 4. 4 i 5. 1 w odniesieniu do danych w różnych grupach wiekowych. należy uwzględnić oficjalne zalecenia dotyczące właściwego stosowania antybiotyków agentów.