Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

mylan ireland limited, unit 35/36 grange parade, baldoyle industrial estate, dublin 13, irska - сунитиниб - kapsula, tvrda - 50 mg - urbroj: jedna kapsula sadrži 50 mg sunitiniba

Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

bausch health ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - takrolimus hidrat - mast - 0,1% - urbroj: 1 g masti sadrži takrolimus hidrat koji odgovara 1,0 mg takrolimusa

Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

bausch + lomb ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - dorzolamidklorid timololmaleat - kapi za oko, otopina - 20 mg/ml + 5 mg/ml - urbroj: 1 ml otopine sadrži 20 mg dorzolamida (u obliku dorzolamidklorida) i 5 mg timolola (u obliku timololmaleata)

Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

bausch health ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - takrolimus hidrat - mast - urbroj: 1 gram masti sadrži 0,3 mg takrolimusa u obliku hidrata

Euroopan unioni - kroatia - 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.

Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

mylan ireland limited, unit 35/36 grange parade, baldoyle industrial estate, dublin 13, irska - dienogest - tableta - 2 mg - urbroj: jedna tableta sadrži 2 mg dienogesta

Euroopan unioni - kroatia - 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.

Euroopan unioni - kroatia - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatid - angina, unstable; myocardial infarction - antitrombotska sredstva - integrilin je namijenjen za uporabu s acetilsalicilnom kiselinom i nefrakcioniranim heparinom. integrilin je indiciran za prevenciju ranog infarkta miokarda kod pacijenata sa nestabilnom anginom i ne-q-инфарктом miokarda s posljednja epizoda bol u prsima javlja u roku od 24 sata s promjenama u ekg-om i / ili povišene razine enzima кардиоспецифических. pacijentu je vjerojatno da će imati koristi od liječenja integrilin one visoki rizik od razvoja infarkta miokarda u prvih 3-4 dana nakon pojave akutnih simptoma angine uključujući, na primjer one koje se mogu proći u početku чрескожная транслюминальная koronarna angioplastika endovaskularno (ptca).

Kroatia - kroatia - HALMED (Agencija za lijekove i medicinske proizvode)

bausch + lomb ireland limited, 3013 lake drive, citywest business campus, dublin 24, irska - travoprost timololmaleat - kapi za oko, otopina - 40 mikrograma/ml + 5 mg/ml - urbroj: svaki ml otopine sadrži 40 mikrograma travoprosta i 5 mg timolola (u obliku timololmaleata)

Euroopan unioni - kroatia - 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.