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

novatin limited, 230, second floor, eucharistic congress road, mosta, malta - sitagliptinklorid hidrat metforminklorid - filmom obložena tableta - urbroj: jedna tableta sadrži sitagliptinklorid hidrat u količini od 50 mg sitagliptina i 1000 mg metforminklorida

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

novatin limited, 230, second floor, eucharistic congress road, mosta, malta - sitagliptinklorid hidrat metforminklorid - filmom obložena tableta - urbroj: jedna tableta sadrži sitagliptinklorid hidrat u količini od 50 mg sitagliptina i 850 mg metforminklorida

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)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - imunosupresivi - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, sitagliptin hydrochloride monohydrate - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus:it is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. it is indicated in combination with a sulphonylurea (i. trostruki kombinovanu terapiju) kao dodatak prehrani i vježbe kod pacijenata, nedovoljno kontroliranim o njihovo maksimalno переносимой doze метформина i sulfonilurejom. it is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (pparγ) agonist (i. , a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a pparγ agonist. it is also indicated as add-on to insulin (i. , triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.

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

aristo pharma gmbh, wallenroder strasse 8-10, berlin, njemačka - tikagrelor - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 60 mg tikagrelora

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

aristo pharma gmbh, wallenroder strasse 8-10, berlin, njemačka - tikagrelor - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 90 mg tikagrelora

Europska Unija - hrvatski - EMA (European Medicines Agency)

laboratoire francais du fractionnement et des biotechnologies - eptacog beta (activated) - hemophilia a; hemophilia b - antihemorrhagics - cevenfacta is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors viii or ix (i. ≥5 bethesda units (bu)); in patients with congenital haemophilia with low titre inhibitors (bu.

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

stada d.o.o., hercegovačka 14, zagreb, hrvatska - teriflunomid - filmom obložena tableta - urbroj: jedna filmom obložena tableta sadrži 14 mg teriflunomida

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

viatris limited, damastown industrial park, mulhuddart, dublin, irska - metotreksat - otopina za injekciju u napunjenoj štrcaljki - urbroj: svaka štrcaljka sa 0,267 ml otopine sadrži 10 mg metotreksata