Europos Sąjunga - slovakų - 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.

Europos Sąjunga - slovakų - 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.

Europos Sąjunga - slovakų - 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.

Europos Sąjunga - slovakų - 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.

Europos Sąjunga - slovakų - 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.

Europos Sąjunga - slovakų - EMA (European Medicines Agency)

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

Europos Sąjunga - slovakų - EMA (European Medicines Agency)

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - pľúcna choroba, chronická obštrukcia - formoterol a glycopyrronium bromid - bevespi aerosphere je uvedené ako údržby bronchodilatačnú liečbu k úľave od príznakov u dospelých pacientov s chronickou obštrukčnou chorobou (chochp).

Europos Sąjunga - slovakų - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - s drogami, vedľajších Účinkov a nežiaducich reakcií - všetky ostatné terapeutické produkty - pre dospelých pacientov liečených s priamym faktor xa (fxa) inhibítor (apixaban alebo rivaroxaban), keď storno použitím prípravkov je potrebné z dôvodu ohrozujúceho život alebo nekontrolované krvácanie.

Europos Sąjunga - slovakų - EMA (European Medicines Agency)

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - pľúcna choroba, chronická obštrukcia - drogy obštrukčnej choroby dýchacích ciest, - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long acting beta2 agonist or combination of a long-acting beta2 agonist and a long acting muscarinic antagonist.

Europos Sąjunga - slovakų - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - leukémia, lymfocytárna, chronická, b-bunka - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.