Unia Europejska - chorwacki - EMA (European Medicines Agency)

amryt pharmaceuticals dac - octreotide acetate - acromegaly - hipofiza i hipotalamusni hormoni i analozi - mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazola - shizofrenija - psycholeptics - održavanje liječenja shizofrenije u odraslih bolesnika stabilizirano je oralnim aripiprazolom.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

mylan pharmaceuticals limited - deferasirox - iron overload; beta-thalassemia - Željeza chelation - Деферазирокс mylan u naznačeno za liječenje kronične preopterećenje željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u bolesnika s beta-талассемией gradonačelnik u dobi od 6 godina i olderthe liječenje kronične preko-zasićenih željezom zbog трансфузий krvi, kada je terapija дефероксамином kontraindiciran ili неадекватна od sljedećih skupina bolesnika:kod pedijatrijska bolesnika s beta-талассемией s preopterećenje željezom zbog čestih переливаний krvi (≥7 ml/kg/mjesec эритроцитарной mase) u dobi od 2 do 5 godina,u pedijatrijskoj i odraslih pacijenata s beta-талассемией s preopterećenje željezom zbog rijedak transfuziju krvi (.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin sun is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. a thiazolidinedione) when use of a pparγ agonist is appropriate and when diet and exercise plus the pparγ agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a pparγ agonist and metformin when use of a pparγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin sun is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - teriparatid - osteoporosis; osteoporosis, postmenopausal - homeostaza kalcija - teriparatide sun is indicated in adults. treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated. treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mukopolisaharidoza ii - drugi gastrointestinalni trakt i metabolizam, lijekovi, - elaprase je indiciran za dugotrajno liječenje bolesnika sa hunter sindrom (mukopolisaharidozom ii, gpp ii). heterozigotne ženke nisu proučavane u kliničkim ispitivanjima.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - velagluceraza alfa - gaucherova bolest - drugi gastrointestinalni trakt i metabolizam, lijekovi, - vpriv je indiciran za dugoročnu zamjensku enzimsku terapiju (ert) u bolesnika s tipom 1 gaucherove bolesti.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - sindromi malapsorpcije - drugi gastrointestinalni trakt i metabolizam, lijekovi, - revestive je indiciran za liječenje bolesnika starijih od jedne godine i više s sindromom kratkog crijeva (sbs). pacijenti bi trebali biti stabilni nakon perioda crijevne adaptacije nakon operacije. revestive indiciran za liječenje bolesnika u dobi od 1 godine i više sa sindromom kratkog crijeva . pacijenti bi trebali biti stabilni nakon perioda crijevne adaptacije nakon operacije.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

chiesi farmaceutici spa - citrat kofeina - apneja za vrijeme - psychoanaleptics, - liječenje primarnog apneja za vrijeme rođene novorođenčadi.

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

novartis hrvatska d.o.o., radnička cesta 37b, zagreb, hrvatska - ciklosporin - kapsula, meka - 100 mg - urbroj: svaka kapsula sadrži 100 mg ciklosporina