Europska Unija - hrvatski - EMA (European Medicines Agency)

biomarin international limited - valoctocogene roxaparvovec - antihemorrhagics - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Europska Unija - hrvatski - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemofilija b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Europska Unija - hrvatski - EMA (European Medicines Agency)

uniqure biopharma b.v.  - alipogen tiparvovec - hyperlipoproteinemia type i - sredstva za modifikaciju lipida - glybera je indicirana za odrasle pacijente s dijagnozom obiteljskog deficita lipaze lipoproteina (lpld) i koji pate od teških ili višestrukih napada pankreatitisa unatoč ograničenjima prehrambenih masnoća. dijagnoza lpld mora biti potvrđena genetskim testiranjem. oznaka je ograničena na pacijente s detektabilnim razinama lpl proteina.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

unifarm d.o.o. lukavac - omeprazole - gastrorezistentna kapsula, tvrda - 20 mg/1 kapsula - 1 gastrorezistentna kapsula, tvrda sadrži: 20 mg omeprazola

Europska Unija - hrvatski - EMA (European Medicines Agency)

d&a pharma - natrij oksibat - substance withdrawal syndrome; alcohol abstinence - ostali lijekovi protiv živčanog sustava - substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.

Europska Unija - hrvatski - 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - lumacaftor, ivacaftor - cistična fibroza - drugi proizvodi respiratornog sustava - tablete orkambi rezultati za liječenje муковисцидоза (mv) kod bolesnika u dobi od 6 i više godina, koji su гомозиготами na mutacije f508del u genu cftr . 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.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

orion corporation, orionintie 1, espoo, finska - varfarinnatrij - tableta - 3 mg - urbroj: jedna tableta sadrži 3 mg varfarinnatrija

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

orion corporation, orionintie 1, espoo, finska - varfarinnatrij - tableta - 5 mg - urbroj: jedna tableta sadrži 5 mg varfarinnatrija

Europska Unija - hrvatski - 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.