Evrópusambandið - króatíska - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - Геморрагическая groznice ebole - cjepiva - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Evrópusambandið - króatíska - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - cjepiva - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Evrópusambandið - króatíska - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - cjepiva - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Bosnía og Hersegóvína - króatíska - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

organon bh d.o.o. - alendronska kiselina, holekalciferol - tableta - 70 mg/1 tableta+ 70 µg/1 tableta - 1 tableta sadrži: 70 mg alendronska kiselina (u obliku alendronatnatrijuma) 70 mcg (2800 i.j.) holekalciferol (u obliku vitamina d3 100 000 i.j./g)

Evrópusambandið - króatíska - EMA (European Medicines Agency)

pharmaxis europe limited - manitol - cistična fibroza - kašalj i hladno pripremanje - bronchitol indiciran za liječenje муковисцидоза (mv) kod odraslih u dobi od 18 godina i stariji, kao i dodatne terapije za bolji standard liječenja.

Evrópusambandið - króatíska - EMA (European Medicines Agency)

santen oy - ciklosporin - bolesti rožnice - ophthalmologicals - liječenje teške keratitisa u odraslih bolesnika s suho oko bolesti, što je oplemenjen usprkos suza zamjene.

Evrópusambandið - króatíska - 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.

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb, hrvatska - tenofovirdizoproksilfumarat - filmom obložena tableta - 245 mg - urbroj: jedna filmom obložena tableta sadrži 245 mg tenofovirdizoproksila (u obliku fumarata)

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

alvogen ipco s.ar.l., 5, rue heienhaff, senningerberg, luksemburg - voriconazolum - filmom obložena tableta - 50 mg - urbroj: svaka tableta sadrži 50 mg vorikonazola

Króatía - króatíska - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - vorikonazol - filmom obložena tableta - 50 mg - urbroj: jedna tableta sadrži 50 mg vorikonazola