Unia Europejska - chorwacki - 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.

Unia Europejska - chorwacki - 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.

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

medic d.o.o., zagreb - reguliranje protoka cerebrospinalne tekućine i odvođenje cerebrospinalne tekućine

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

sonimed d.o.o., zagreb - regulacija tjelesne temperature, hlađenje i grijanje tijela

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

otos ortopedska tehnika d.o.o. vukovarska 1 31000 osijek -

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

sljeme dental d.o.o., zagreb - stomatološki materijal, materijal za uzimanje otisaka

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

medical intertrade d.o.o. dr. franje tuđmana 3 10431 sveta nedelja -

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

elektroničar d.o.o. karlovačka cesta 26/a 10000 zagreb -

Chorwacja - chorwacki - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

dechra regulatory b.v., handelsweg 25, 5531 ae bladel, nizozemska - apomorfinklorid hemihidrat - otopina za injekciju - agonisti dopamina - pasa

Chorwacja - chorwacki - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

dechra regulatory b.v., handelsweg 25, 5531 ae bladel, nizozemska - klindamicin (u obliku klindamicinklorida) - tablete za žvakanje - antibakterijski lijekovi za sustavnu primjenu, linkozamidi - pasa, mačaka