Euroopa Liit - saksa - EMA (European Medicines Agency)

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.

Euroopa Liit - saksa - EMA (European Medicines Agency)

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.

Euroopa Liit - saksa - EMA (European Medicines Agency)

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.

Saksamaa - saksa - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

astrazeneca gmbh (3079338) - budesonid; formoterolfumarat-dihydrat (ph.eur.); budesonid; formoterolfumarat-dihydrat (ph.eur.) - druckgasinhalation, suspension - budesonid (18667) 160 mikrogramm; formoterolfumarat-dihydrat (ph.eur.) (23761) 4,5 mikrogramm; budesonid (18667) 160 mikrogramm; formoterolfumarat-dihydrat (ph.eur.) (23761) 4,5 mikrogramm

Euroopa Liit - saksa - EMA (European Medicines Agency)

astrazeneca ab - benralizumab - asthma - medikamente für obstruktive atemwegserkrankungen, - fasenra ist angezeigt als add-on erhaltungstherapie bei erwachsenen patienten mit schwerem eosinophilen asthma nicht ausreichend kontrolliert, trotz hoher dosis, inhalative corticosteroide plus langwirksame β-agonisten.

Euroopa Liit - saksa - EMA (European Medicines Agency)

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).

Euroopa Liit - saksa - EMA (European Medicines Agency)

astrazeneca ab - andexanet alfa - medikament-nebenwirkungen und nachteilige reaktionen - alle anderen therapeutischen produkte - für erwachsene patienten, die mit einem direkten faktor-xa - (fxa) - hemmer (apixaban oder rivaroxaban) bei der umkehrung der antikoagulation erforderlich ist wegen lebensbedrohender oder unkontrollierte blutungen.

Austria - saksa - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gebro pharma gmbh - ezetimib; rosuvastatin calcium -

Austria - saksa - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gebro pharma gmbh - ezetimib; rosuvastatin calcium -

Austria - saksa - AGES (Agentur für Gesundheit und Ernährungssicherheit)

gebro pharma gmbh - ezetimib; rosuvastatin calcium -