Unione Europea - croato - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Croazia - croato - HALMED (Agencija za lijekove i medicinske proizvode)

stada d.o.o., hercegovačka 14, zagreb, hrvatska - dimetilfumarat - Želučanootporna kapsula, tvrda - urbroj: jedna tvrda želučanootporna kapsula sadrži 120 mg dimetilfumarata

Croazia - croato - HALMED (Agencija za lijekove i medicinske proizvode)

stada d.o.o., hercegovačka 14, zagreb, hrvatska - dimetilfumarat - Želučanootporna kapsula, tvrda - urbroj: jedna tvrda želučanootporna kapsula sadrži 240 mg dimetilfumarata

Croazia - croato - HALMED (Agencija za lijekove i medicinske proizvode)

stada d.o.o., hercegovačka 14, zagreb, hrvatska - solifenacinsukcinat tamsulozinklorid - tableta s prilagođenim oslobađanjem - urbroj: svaka tableta s prilagođenim oslobađanjem sadrži 6 mg solifenacinsukcinata, što odgovara 4,5 mg solifenacina i 0,4 mg tamsulozinklorida, što odgovara 0,37 mg tamsulozina