Kroatië - Kroatisch - HALMED (Agencija za lijekove i medicinske proizvode)

mcneil healthcare (ireland) limited, tallaght, high street, office 5, 6 & 7, block 5, dublin, irska - heksetidin - sprej za usnu sluznicu, otopina - 2 mg/ml - urbroj: jedan ml otopine sadrži 2 mg heksetidina

Bosnië en Herzegovina - Kroatisch - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

inel d.o.o - tehnecijum (99mtc) pertehnetat - radionuklidni generator - 2,15 gigabq/1 dan i sat kalibracije 43 gigabq/1 dan i sat kalibracije+ 1,9 gigabq/1 boca 38,1 gigabq/1 boca - 1 radionuklidni generator sadrži 2.1543 gigbq matičnog izotopa 99mo, koji je adsorbovan na hromatografskoj koloni; eluiranjem isporučuje 1.9038.10 gigbq 99mtc u obliku natrijumpertehnetat rastvora za injekciju; 99mtc se raspada uz emisiju gama zračenja sa prosječnom energijom 140 kev i vremenom poluraspada 6,01 sati

Montenegro - Kroatisch - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"glk pharma" druŠtvo sa ograniČenom odgovornoŠĆu, budva - hlorpromazin - film tableta - 25mg

Montenegro - Kroatisch - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

dio stranog druŠtva "krka d.d. novo mesto" slovenija - predstavniŠtvo podgorica - flufenazin - obložena tableta - 1mg

Montenegro - Kroatisch - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

dio stranog druŠtva "krka d.d. novo mesto" slovenija - predstavniŠtvo podgorica - flufenazin - obložena tableta - 5mg

Montenegro - Kroatisch - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

dio stranog druŠtva "krka d.d. novo mesto" slovenija - predstavniŠtvo podgorica - flufenazin - obložena tableta - 2.5mg

Europese Unie - Kroatisch - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - 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.

Europese Unie - Kroatisch - EMA (European Medicines Agency)

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

Europese Unie - Kroatisch - EMA (European Medicines Agency)

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