Forxiga Eiropas Savienība - vācu - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapagliflozin-propandiol-monohydrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - drogen bei diabetes verwendet - 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. zusätzlich zu anderen arzneimitteln für die behandlung von typ-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 und 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.

Komboglyze Eiropas Savienība - vācu - EMA (European Medicines Agency)

komboglyze

astrazeneca ab  - metformin hydrochlorid, saxagliptin hydrochlorid - diabetes mellitus, typ 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - komboglyze wird angezeigt, als ergänzung zu diät und bewegung zur verbesserung der glykämischen kontrolle bei erwachsenen patienten im alter von 18 jahren und älter mit typ-2 diabetes mellitus unzureichend auf die maximal tolerierte dosis von metformin allein kontrolliert oder personen, die bereits mit der kombination aus saxagliptin und metformin als separate tabletten behandelt. komboglyze ist auch indiziert in kombination mit insulin (i. die dreifach-kombinationstherapie) als ergänzung zu diät und bewegung zur verbesserung der glykämischen kontrolle bei erwachsenen patienten im alter von 18 jahren und älter mit typ-2-diabetes mellitus, wenn insulin und metformin allein keine ausreichende glykämischer kontrolle.

Lynparza Eiropas Savienība - vācu - EMA (European Medicines Agency)

lynparza

astrazeneca ab - olaparib - eierstock-neoplasmen - antineoplastische mittel - eierstock cancerlynparza ist angezeigt als monotherapie zur erhaltungstherapie von erwachsenen patienten mit fortgeschrittenem (figo-stadien iii und iv) brca1/2-mutierten (keimbahn und/oder somatisch) high-grade-epithelialen eierstockkrebs, eileiterkrebs oder primärem peritonealkarzinom, die in reaktion (vollständige oder teilweise) nach abschluss der first-line-chemotherapie auf platinbasis. 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 und 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. sollten patienten, die zuvor behandelt wurden, mit einem anthrazyklin und einem taxan in der (neo)adjuvanten oder metastasierten setting, es sei denn, die patienten waren nicht geeignet für diese behandlung (siehe abschnitt 5. patienten mit hormon-rezeptor (hr)-positivem brustkrebs sollten auch fortgeschritten, die am oder nach vorheriger endokriner therapie, oder werden als ungeeignet für die endokrine therapie. 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.

Tagrisso Eiropas Savienība - vācu - EMA (European Medicines Agency)

tagrisso

astrazeneca ab - osimertinib mesilate - karzinom, nicht kleinzellige lunge - andere antineoplastische wirkstoffe, die protein-kinase-inhibitoren - 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.

Onglyza Eiropas Savienība - vācu - EMA (European Medicines Agency)

onglyza

astrazeneca ab - saxagliptin - diabetes mellitus, typ 2 - drogen bei diabetes verwendet - 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.

Bevespi Aerosphere Eiropas Savienība - vācu - EMA (European Medicines Agency)

bevespi aerosphere

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - lungenerkrankung, chronisch obstruktiv - formoterol und glycopyrronium bromid - bevespi aerosphere angegeben ist eine wartung bronchodilatator-behandlung zur linderung der symptome bei erwachsenen patienten mit chronisch-obstruktiver lungenerkrankung (copd).

Trixeo Aerosphere Eiropas Savienība - vācu - EMA (European Medicines Agency)

trixeo aerosphere

astrazeneca ab - formoterol fumarate dihydrate, glycopyrronium bromide, budesonide - lungenerkrankung, chronisch obstruktiv - medikamente für obstruktive atemwegserkrankungen, - 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.

Calquence Eiropas Savienība - vācu - EMA (European Medicines Agency)

calquence

astrazeneca ab - acalabrutinib - leukämie, lymphozytär, chronisch, b-zell - 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.

Riltrava Aerosphere Eiropas Savienība - vācu - EMA (European Medicines Agency)

riltrava aerosphere

astrazeneca ab - budesonide, formoterol fumarate dihydrate, glycopyrronium bromide - lungenerkrankung, chronisch obstruktiv - medikamente für obstruktive atemwegserkrankungen, - riltrava 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 (for effects on symptoms control and prevention of exacerbations see section 5.

Imjudo Eiropas Savienība - vācu - EMA (European Medicines Agency)

imjudo

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastische mittel - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.