Adempas האיחוד האירופי - פולנית - EMA (European Medicines Agency)

adempas

bayer ag - riociguat - nadciśnienie tętnicze, płucne - leki hipotensyjne do nadciśnienia płucnego - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. skuteczność wykazano w populacji tfu tym etiologii samoistna lub dziedziczna lub tfu tfu, związane z chorobami tkanki łącznej . paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Adcirca (previously Tadalafil Lilly) האיחוד האירופי - פולנית - EMA (European Medicines Agency)

adcirca (previously tadalafil lilly)

eli lilly nederland b.v. - tadalafil - nadciśnienie tętnicze, płucne - urologiczne - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. wykazano skuteczność w idiopatycznym pah (ipah) i w pah związane z kolagenozę. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Kalydeco האיחוד האירופי - פולנית - 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.

Volibris האיחוד האירופי - פולנית - EMA (European Medicines Agency)

volibris

glaxosmithkline (ireland) limited - ambrisentan - nadciśnienie tętnicze, płucne - jednak leki, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.