European Union - English - EMA (European Medicines Agency)

astrazeneca ab - durvalumab - carcinoma, non-small-cell lung - antineoplastic agents - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5.1).imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc).biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc).hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastic agents - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 55831 - denture base resin kit, self-cured - flexcera base is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. the material is an alternative to traditional heat-curable and auto polymerizing resins. flexcera base is intended exclusively for professional dental work. fabrication of denture bases with flexcera base requires a computer-aided and manufacturing (cad/cam) system that includes the following components: digital denture base-files based on a digital impression, a digital light processing (dlp) printer, and curing light equipment.

Australia - English - Department of Health (Therapeutic Goods Administration)

straumann pty ltd -

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - 16730 - denture base resin, cured - resin for dental 3d printing of denture bases, splints, orthodontic bases, surgical guides and x-ray templates for dentistry, occlusal orthos, fixation and transfer keys.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab - concentrate for solution for infusion - nivolumab 10 mg/ml - nivolumab - unresectable or metastatic melanoma:opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.adjuvant treatment of melanoma:opdivo is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage iib, iic, iii, or iv melanoma.metastatic non-small cell lung cancer:- opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (nsclc), with no egfr or alk genomic tumor aberrations.- opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (nsclc) with progression on or after platinum-based chemotherapy.renal cell carcinoma:- opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) in patients who have received prior anti-angiogenic therapy.- opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (rcc).- opdivo, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced rcc.classical hodgkin lymphoma:opdivo is indicated for the treatment of adult patients with classical hodgkin lymphoma (chl) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (hsct) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous hsct.squamous cell carcinoma of the head and neck:opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (scchn) with disease progression on or after platinum-based therapy.microsatellite instability-high (msi-h) or mismatch repair deficient(dmmr) metastatic colorectal cancer:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) metastatic colorectal cancer (crc) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.urothelial carcinoma:- opdivo is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (uc) who are at high risk of recurrence after undergoing radical resection of uc.- opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.hepatocellular carcinoma:opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (hcc) child-pugh a who have been previously treated with sorafenib.esophageal cancer:-opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (crt). -opdivo is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.-opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.malignant pleural mesothelioma:opdivo, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma:opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.neoadjuvant treatment of resectable non-small cell lung cancer:opdivo, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (nsclc).

Israel - English - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 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 cancer lynparza 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.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza

Israel - English - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 100 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.

Israel - English - 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 cancer lynparza 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.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza