Unión Europea - croata - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - imunosupresivi - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Unión Europea - croata - EMA (European Medicines Agency)

era consulting gmbh - pegfilgrastim - neutropenija - Иммуностимуляторы, , колониестимулирующие faktori - smanjenje duljine trajanja neutropenije i incidencije febrilne neutropenije u odraslih bolesnika liječenih citotoksičnom kemoterapijom zbog zloćudne bolesti (uz iznimku kronične mijeloične leukemije i mijelodisplastičnog sindroma).

Croacia - croata - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

zoetis b.v., podružnica zagreb za promidžbu, petra hektorovića 2, zagreb, hrvatska - novobiocin; neomicin; benzilpenicilinprokain ; dihidrostreptomicin; prednizolon - intramamarna suspenzija - antibakterijski vmp za intramamarnu primjenu - goveda (krava u laktaciji)

Croacia - croata - Ministarstvo poljoprivrede, Uprava za Veterinarstvo i sigurnost hrane

zoetis b.v., podružnica zagreb za promidžbu, petra hektorovića 2, zagreb, hrvatska - novobiocin; neomicin; benzilpenicilinprokain ; dihidrostreptomicin; prednizolon - intramamarna suspenzija - goveda (krava u laktaciji)

Bosnia y Herzegovina - croata - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

unifarm d.o.o. lukavac - benzilpenicilinkalijum, benzilpenicilinprokain - prašak i rastvarač za rastvor za injekciju - 200000 i.j./1 bočica+ 600000 i.j./1 bočica - 1 bočica praška za rastvor za injekcijusadrži: 125 mg kalijum penicilina g što je ekvivalentno 200 000 i.j./bočici 600 mg prokain penicilina g što je ekvivalentno 600 000 i.j./bočici

Unión Europea - croata - EMA (European Medicines Agency)

bayer ag - damoctocog alfa pegol - hemofilija a - antihemorrhagics - prevencija i liječenje krvarenja kod ranije леченных bolesnika ≥ 12 godina s гемофилией a (urođeni deficit faktora viii)u.

Unión Europea - croata - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemijski pripravci - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Unión Europea - croata - EMA (European Medicines Agency)

zoetis belgium sa - live recombinant e2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus e2 gene (cp7_e2alf) - live viral vaccines, immunologicals for suidae - svinje - za aktivnu imunizaciju svinja od sedam tjedana pa nadalje kako bi se spriječila smrtnost i smanjila infekcija i bolesti uzrokovane virusom klasične svinjske kuge (csfv). onset of immunity: 14 days after vaccinationduration of immunity: at least 6 months after vaccinationfor active immunisation of breeding females to reduce transplacental infection caused by csfv. onset of immunity: 21 days after vaccinationduration of immunity has not been demonstrated.

Unión Europea - croata - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Unión Europea - croata - 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.