유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

recordati rare diseases - betain bezvodni - homocistinuriju - drugi gastrointestinalni trakt i metabolizam, lijekovi, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

유럽 연합 - 크로아티아어 - 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.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastična sredstva - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuklidno slikanje - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sitagliptin fumarate, metformin hydrochloride - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - for adult patients with type 2 diabetes mellitus:sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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. sitagliptin/metformin hydrochloride sun 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.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

alexion europe sas - sebelipaza alfa - metabolizam lipida, urođene pogreške - drugi gastrointestinalni trakt i metabolizam, lijekovi, - kanuma je indiciran za dugoročnu zamjensku enzimsku terapiju (ert) u bolesnika svih dobnih skupina s nedostatkom lipaze lizosomalne kiseline (lal).

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinuria, paroxysmal - selektivni imunosupresivi - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

otsuka novel products gmbh - Деламанид - tuberkuloza, višestruko otporna - antimikobakterija - deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (mdr-tb) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see sections 4. 2, 4. 4 i 5. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - dijagnostički radiofarmaceutici - ovaj je lijek samo za dijagnostičku uporabu. nakon radiolabelling s галлием (68га) otopina natrij klorid, malter arsenid (68га) edotreotide dobiti dizajniran za pozitronska emisijska tomografija (pet) vizualizacija receptora somatostatina сверхэкспрессия kod odraslih pacijenata s potvrđene ili percipirane высокодифференцированных gastro-enteropancreatic нейроэндокринные tumora (gap-net) za lokalizaciju primarnog tumora i njihovih metastaza.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - Лучевые oštećenja - detoxifying agents for antineoplastic treatment - lysakare indiciran za smanjenje izloženosti zračenju kada bubrega peptid-рецепторного радионуклидной terapije (prrt) s Лютеций (177lu) oxodotreotide kod odraslih.