Unión Europea - eslovaco - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - ambrisentan - hypertenzia, pľúca - antihypertenzív, - 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.

Unión Europea - eslovaco - 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.

Unión Europea - eslovaco - 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.

Unión Europea - eslovaco - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystická fibróza - ostatné produkty dýchacej sústavy - 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.

Unión Europea - eslovaco - EMA (European Medicines Agency)

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

Eslovaquia - eslovaco - ŠÚKL (Štátny ústav pre kontrolu liečiv)

mylan ireland limited, Írsko - kapecitabín - 44 - cytostatica

Unión Europea - eslovaco - EMA (European Medicines Agency)

pfizer limited - celecoxib - adenomatózna polypóza coli - antineoplastické činidlá - onsenal je indikovaný na zníženie počtu adenomatóznej Črevné polypy v familiárnej adenomatóznej polypózy (fap), ako doplnok chirurgia a ďalšie endoskopické sledovanie (pozri časť 4. Účinok onsenal vyvolaných zníženie polyp záťaž na riziko črevnej rakovina nebola preukázaná (pozri časť 4. 4 a 5.

Unión Europea - eslovaco - EMA (European Medicines Agency)

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

Unión Europea - eslovaco - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - daunorubicin hydrochloride, cytarabine - leukémia, myeloidná, akútna - antineoplastické činidlá - vyxeos liposomal je indikovaný na liečbu dospelých pacientov s novo diagnostikovanou, terapie, súvisiace s akútna myeloidná leukémia (t-aml) alebo aml s myelodysplasia zmeny týkajúce sa (aml-mrk).

Unión Europea - eslovaco - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - prekurzorová bunková lymfoblastická leukémia-lymfóm - antineoplastické činidlá - 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.