Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistična fibroza - drugi proizvodi dihal - orkambi tablete so primerna za zdravljenje cistična fibroza (cf) pri bolnikih, starih 6 let in več, ki so homozygous za f508del mutacije v cftr gena. 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi dihal - 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 in 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 in 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - tezacaftor, ivacaftor - cistična fibroza - drugi proizvodi dihal - 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cistična fibroza - drugi proizvodi dihal - 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.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

vertex pharmaceuticals (europe) limited - ivakaftor - zrnca - ivakaftor 50 mg / 1 vrečica - ivakaftor

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

vertex pharmaceuticals (europe) limited - ivakaftor - zrnca - ivakaftor 75 mg / 1 vrečica - ivakaftor

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

vertex pharmaceuticals (europe) limited - ivakaftor, lumakaftor - filmsko obložena tableta - ivakaftor 125 mg / 1 tableta; lumakaftor 200 mg / 1 tableta - ivakaftor and lumakaftor

Evropska unija - slovenščina - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karcinom, pljučni pljuč - antineoplastična sredstva - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - oftalmologi - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).