Unia Europejska - polski - EMA (European Medicines Agency)

ultragenyx germany gmbh - evinacumab - hipercholesterolemia - Środki modyfikujące poziom lipidów - evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (ldl-c) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (hofh).

Unia Europejska - polski - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesylate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - Środki przeciwnowotworowe - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacjenci, którzy mają niskie lub bardzo niskie ryzyko nawrotu, nie powinni otrzymywać leczenie uzupełniające. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. za wyjątkiem zdiagnozowanych fazie przewlekłej cml, nie ma kontrolowanych badań, które wykazują efekt kliniczny lub zwiększa przeżywalność przy tych chorobach.

Unia Europejska - polski - EMA (European Medicines Agency)

kyowa kirin holdings b.v. - istradefylline - choroba parkinsona - leki przeciw chorobie parkinsona - istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with parkinson’s disease (pd) experiencing “off” time.

Unia Europejska - polski - EMA (European Medicines Agency)

novo nordisk a/s - semaglutide - obesity; overweight - preparaty przeciw otyłości, z wył. produkty dietetyczne - wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (bmi) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to.

Unia Europejska - polski - EMA (European Medicines Agency)

bial portela & companhia s.a. - opicapone - choroba parkinsona - leki przeciw chorobie parkinsona - ontilyv is indicated as adjunctive therapy to preparations of levodopa/ dopa decarboxylase inhibitors (ddci) in adult patients with parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Unia Europejska - polski - EMA (European Medicines Agency)

serb sa - betaine - homocystynuria - inne przewodu pokarmowego i przemianę materii narzędzia, - amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:•         cystathionine beta-synthase (cbs),•         5,10 methylene tetrahydrofolate reductase (mthfr),•         cobalamin cofactor metabolism (cbl).

Unia Europejska - polski - EMA (European Medicines Agency)

accord healthcare s.l.u. - metformin hydrochloride, vildagliptin - diabetes mellitus, type 2 - leki stosowane w cukrzycy - 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 dla dostępnych danych o różnych kombinacjach).

Unia Europejska - polski - EMA (European Medicines Agency)

eli lilly nederland b.v. - tirzepatide - diabetes mellitus, type 2 - leki stosowane w cukrzycy - mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications- in addition to other medicinal products for the treatment of diabetes. for study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4. 4, 4. 5 i 5.

Unia Europejska - polski - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - leki stosowane w cukrzycy - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - inne przeciwpadaczkowe narzędzia - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.