Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

ipsen pharma, 65 quai georges gorse, boulogne-billancourt, francuska - neurotoksin clostridium botulinum tip a - hemaglutininski kompleks - otopina za injekciju - urbroj: 125 speywood jedinica botulinskog toksina tipa a u 0,625 ml otopine u bočici

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

ipsen pharma, 65 quai georges gorse, boulogne-billancourt, francuska - neurotoksin clostridium botulinum tip a - hemaglutininski kompleks - prašak za otopinu za injekciju - urbroj: 125 speywood jedinica botulinskog toksina tipa a u prašku u bočici

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - neoplazme štitnjače - antineoplastična sredstva - liječenje odraslih bolesnika s progresivnim, neosjetljivim lokalno naprednim ili metastaznim karcinomom medularnog štitnjače.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laronov sindrom - hipofiza i hipotalamusni hormoni i analozi - za dugotrajno liječenje zatajenja rasta u djece i adolescenata s teškim primarne inzulin-kao-rasta-faktor-1 nedostatak (primarni igfd). teška primarne igfd određuje:standardna visina odstupanja rezultat ≤ -3. 0;bazalni inzulin-sličan faktor rasta-1 (igf-1) razine ispod 2. 5. percentile za dob i spol;hormon rasta (gh) adekvatnost;iznimka je sekundarni oblik igf-1 deficit, kao što su гипотрофия, hipotireoza, ili kronični tretman farmakološke doze anti steroida. izražene igfd uključuje bolesnika s mutacije u genu gr receptor (usd), stup-blaženstvo signalnog putu, i igf-1, gen nedostatke; oni ne gh nedovoljan, i tako oni ne mogu odgovoriti adekvatno экзогенным hormon rasta, liječenje. preporučljivo je potvrditi dijagnozu, provode test igf-1 generacija .

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - hipofiza i hipotalamusni hormoni i analozi - dugoročno liječenje djece s neuspjehom rasta zbog neadekvatne endogene sekrecije hormona rasta. dugotrajno liječenje zatajenja rasta povezane s turnerovim sindromom. liječenje kod djece u препубертатном dobi s povećanjem srca, povezana s kroničnom bubrežnom insuficijencijom do transplantacije bubrega. zamjena endogenog hormona rasta kod odraslih osoba s nedostatkom hormona rasta ili dječjoj ili odrasloj dobi etiologije. nedostatak hormona rasta mora biti na odgovarajući način potvrđena prije početka liječenja.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastična sredstva - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy. cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - palovarotene - myositis ossificans - ostali lijekovi za poremećaje mišićno-koštanog sustava - treatment of fibrodysplasia ossificans progressiva.

Europska Unija - hrvatski - EMA (European Medicines Agency)

albireo - odevixibat - cholestasis, intrahepatic - bile i jetrena terapija - bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (pfic) in patients aged 6 months or older (see sections 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord 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 (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary 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 ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - vildagliptin/metformin hydrochloride accord is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:- in patients who are inadequately controlled with metformin hydrochloride alone. - in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. - in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 i 5. 1 za dostupne podatke o različitim kombinacijama).