Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - dapagliflozín propándiol monohydrát - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusforxiga 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 exerciseas monotherapy when metformin is considered inappropriate due to intolerance. okrem iných liekov na liečbu diabetes mellitus 2. typu. 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 a 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab  - hydrochlorid metformín, saxagliptin hydrochlorid - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze je indikovaná ako doplnok diéty acvičenia scieľom zlepšiť kontrolu glykémie udospelých pacientov vo veku 18rokov a starších s diabetommellitus typu 2 u pacientov nedostatočne kontrolovaných maximálne tolerovanou dávkou samotného metformínu alebo tie, ktoré už sú liečených kombináciou saxagliptínu a metformínu ako samostatné tablety. komboglyze je tiež uvedené v kombinácii s inzulínom (i. triple kombinovaná liečba) ako doplnok stravy a cvičenia na zlepšenie glykemický kontroly u dospelých pacientov vo veku 18 rokov a starších s typu 2 diabetes mellitus, keď inzulínom a metformínom sám neposkytujú dostatočnú glykemický ovládanie.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovariálne nádory - antineoplastické činidlá - ovariálnych cancerlynparza je označené ako monotherapy pre:udržiavaciu liečbu dospelých pacientov s pokročilým (figo fázy iii a iv) brca1/2-zmutoval (germline a/alebo somatických) high-grade epitelové vaječníkov, fallopian trubice alebo primárne peritoneal rakovine, ktorí sú v reakcii (úplné alebo čiastočné) po ukončení prvej línie platinum-založené chemoterapia. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 a 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacienti by mali mať predtým liečení anthracycline a taxane v (neo)adjuvantnej alebo metastatickým nastavenie pokiaľ pacienti neboli vhodné pre tieto liečby (pozri časť 5. u pacientov s hormonálny receptor (hr)-pozitívnou rakovinou prsníka, by tiež mali mať postupoval alebo po pred žliaz s vnútornou sekréciou, terapie, alebo byť považované za nevhodné pre žliaz s vnútornou sekréciou, terapia. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astra zeneca ab - saxagliptin, dapagliflozin propanediol monohydrát - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - lieky používané pri cukrovke - qtern, stabilnej dávke kombinácia saxagliptin a dapagliflozin, je indikovaný u dospelých vo veku 18 rokov a starších s diabetes mellitus 2. typu:ak chcete zvýšiť glykemický kontrolu pri metformínom a/alebo sulfonylmocoviny (su) a jeden z monocomponents z qtern neposkytujú dostatočnú glykemický kontroly,keď už liečená zadarmo zmes dapagliflozin a saxagliptin. (pozri časť 4. 2, 4. 4, 4. 5 a 5. 1 na dostupné údaje o kombinácie študoval.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinóm, pľúc bez malých buniek - iné antineoplastické činidlá, protein kinase inhibítory - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - hydrochlorid metformín, dapagliflozin propanediol monohydrát - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - xigduo je indikovaný u dospelých na liečbu diabetes mellitus 2. typu ako doplnok stravy a cvičenia:• u pacientov s nedostatočne kontrolovanou na ich maximálne tolerované dávkou metformínom sám • v kombinácii s inými liekmi na liečbu cukrovky u pacientov s nedostatočne kontrolovanou s metformínom a tieto lieky• u pacientov, ktorí sa už liečia s kombináciou dapagliflozin a metformínom ako samostatné tablety. pre študijné výsledky s ohľadom na kombináciu terapií, vplyv na glykemický kontroly a kardiovaskulárne udalosti, a populácií študoval, pozri časť 4. 4, 4. 5 a 5.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - saxagliptin - diabetes mellitus, typ 2 - lieky používané pri cukrovke - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus 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 metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - astma - drogy obštrukčnej choroby dýchacích ciest, - fasenra je označené ako pridať na udržiavaciu liečbu dospelých pacientov s ťažkou eozinofilná astma nedostatočne kontrolované napriek vysokými dávkami inhalačných kortikosteroidov, plus dlhodobo pôsobiaceho β-agonistov.

Եվրոպական Միություն - սլովակերեն - EMA (European Medicines Agency)

astrazeneca ab - sodík zirkónia cyclosilicate - hyperkaliémia - všetky ostatné terapeutické produkty - lokelma je indikovaný na liečbu hyperkalaemia u dospelých pacientov.

Սլովակիա - սլովակերեն - ŠÚKL (Štátny ústav pre kontrolu liečiv)

astrazeneca ab, Švédsko - formoterol a budezonid - 14 - bronchodilatantia, antiasthmatica