Israël - Engels - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 150 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) 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. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancerlynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.

Israël - Engels - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 12.30 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older 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. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

Israël - Engels - Ministry of Health

astrazeneca (israel) ltd - dapagliflozin propanediol - film coated tablets - dapagliflozin propanediol 6.150 mg/dose - dapagliflozin - forxiga is indicated:- in adults aged 18 years and older 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. - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (nyha class ii-iv) with reduced ejection fraction- to reduce the risk of sustained egfr decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. limitations of use -forxiga is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. forxiga is not expected to be effective in these populations.

Europese Unie - Estlands - EMA (European Medicines Agency)

astrazeneca ab - reassortant gripi viirus (elus nõrgestatud) järgmised tüvi: a/vietnam/1203/2004 (h5n1) tüve - gripp, inimene - vaktsiinid - gripi profülaktika ametlikult väljakuulutatud pandeemia korral lastel ja noorukitel alates 12 kuu kuni alla 18 aasta vanuse. pandeemilise gripi vaktsiini h5n1 astrazeneca tuleks kasutada vastavalt euroopa liidu arendus.

Europese Unie - Estlands - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - kartsinoom, mitteväikerakk-kopsu - antineoplastilised ained - tremelimumab astrazeneca 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.

Europese Unie - Hongaars - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - karcinóma, nem kissejtes tüdő - daganatellenes szerek - tremelimumab astrazeneca 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.

Europese Unie - Fins - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - karsinooma, ei-pienisoluinen keuhko - antineoplastiset aineet - tremelimumab astrazeneca 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.

Europese Unie - Hongaars - EMA (European Medicines Agency)

astrazeneca ab - a következő törzs reaktivált influenzavírus (élő attenuált): a / vietnam / 1203/2004 (h5n1) törzs - influenza, emberi - a vakcinák - influenza megelőzése hivatalosan bejelentett pandémiás helyzetben 12 hónapos és 18 év alatti gyermekek és serdülőkorúak körében. a pandémiás influenza vaccine h5n1 astrazeneca kell alkalmazni hivatalos ajánlásoknak megfelelően.

Europese Unie - Litouws - EMA (European Medicines Agency)

astrazeneca ab - a / vietnam / 1203/2004 (h5n1) padermės virusas (gyvas susilpnintas). - gripas, žmogus - vakcinos - gripo profilaktika oficialiai paskelbtoje pandemijos situacijoje vaikams ir paaugliams nuo 12 mėnesių iki jaunesnio nei 18 metų amžiaus. pandeminio gripo vakcina h5n1 astrazeneca turėtų būti naudojami laikantis oficialių rekomendacijų.

Europese Unie - Fins - EMA (European Medicines Agency)

astrazeneca ab - (live attenuated) reassortant influenza virus (a / vietnam / 1203/2004 (h5n1) -kanta - influenssa, ihminen - rokotteet - influenssan ennaltaehkäisy virallisesti ilmoitetussa pandemiatilanteessa lapsilla ja nuorilla 12 kuukauden ikäisiltä alle 18-vuotiaille. pandemic influenza vaccine h5n1 astrazeneca tulee käyttää virallisen ohjeistuksen mukaisesti.