Namibia - English - Namibia Medicines Regulatory Council

pharmacare limited - dichlorophene, triclosan - liquid in aerosol - each 150ml liquid contains; dichlorophene 0.0935 g, triclosan 0.0312 g

Namibia - English - Namibia Medicines Regulatory Council

pharmacare limited - zinc oxide ; octaphonium chloride - ointment - contains; zinc oxide 7.5%; octaphonium chloride 0.28% m/m

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

astrazeneca pty ltd - olaparib, quantity: 100 mg - tablet, film coated - excipient ingredients: copovidone; colloidal anhydrous silica; mannitol; sodium stearylfumarate; hypromellose; macrogol 400; titanium dioxide; iron oxide yellow - ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients with advanced breast cancer susceptibility gene (brca) mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. brca mutation status should be determined by an experienced laboratory using a validated test method.,? 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) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated 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 (germline or somatic), and/or; genomic instability,hrd status should be determined by an experienced laboratory using a validated test method. ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have advanced, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer with a deleterious or suspected deleterious, breast cancer susceptibility gene (brca) mutation (germline or somatic), which is in response (complete or partial) to first-line platinum-based chemotherapy.,? maintenance treatment of adult patients who have platinum-sensitive relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients who have advanced, epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) to first-line platinumbased chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either:,- a deleterious or suspected deleterious brca mutation (germline or somatic), and/or,- genomic instability adenocarcinoma of the pancreas,lynparza is indicated as monotherapy 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. germline brca mutation (gbrcam) status should be determined by an experienced laboratory using a validated test method. prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients with brca-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer who have progressed following prior therapy that included a new hormonal agent. brca mutation status should be determined by an experienced laboratory using a validated test method. breast cancer,lynparza is indicated as monotherapy for the:,? adjuvant treatment of adult patients who have her2-negative, high-risk early breast cancer with a deleterious or suspected deleterious germline brca mutation (gbrcam), for which they have previously been treated with neoadjuvant or adjuvant chemotherapy.,? treatment of adult patients who have her2-negative metastatic breast cancer with a deleterious or suspected deleterious gbrcam, for which they have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients who have metastatic castration-resistant prostate cancer (mcrpc) with a deleterious or suspected deleterious brca mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent.,lynparza in combination with abiraterone and either prednisone or prednisolone is indicated for the:,? treatment of adult patients who have mcrpc with a deleterious or suspected deleterious brca mutation (germline or somatic). adenocarcinoma of the pancreas,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have metastatic pancreatic adenocarcinoma with a deleterious or suspected deleterious gbrcam, which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

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

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 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.

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

astrazeneca pty ltd - olaparib, quantity: 150 mg - tablet, film coated - excipient ingredients: copovidone; colloidal anhydrous silica; mannitol; sodium stearylfumarate; hypromellose; macrogol 400; titanium dioxide; iron oxide yellow; iron oxide black - ovarian cancer,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have advanced, high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer with a deleterious or suspected deleterious, breast cancer susceptibility gene (brca) mutation (germline or somatic), which is in response (complete or partial) to first-line platinum-based chemotherapy.,? maintenance treatment of adult patients who have platinum-sensitive relapsed, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) after platinum-based chemotherapy. prior treatment must have included at least 2 courses of platinum-based regimens.,lynparza in combination with bevacizumab is indicated for the:,? maintenance treatment of adult patients who have advanced, epithelial ovarian, fallopian tube or primary peritoneal cancer which is in response (complete or partial) to first-line platinumbased chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd)-positive status defined by either:,- a deleterious or suspected deleterious brca mutation (germline or somatic), and/or,- genomic instability breast cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients with germline brca-mutated her2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. germline brca mutation (gbrcam) status should be determined by an experienced laboratory using a validated test method.,lynparza is indicated as monotherapy for the:,? adjuvant treatment of adult patients with brca-mutated her2-negative high risk early breast cancer who have previously been treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 -dose and method of administration and 5.1 -pharmacodynamic properties). prostate cancer,lynparza is indicated as monotherapy for the:,? treatment of adult patients who have metastatic castration-resistant prostate cancer (mcrpc) with a deleterious or suspected deleterious brca mutation (germline or somatic), which has progressed following prior therapy that included a new hormonal agent.,lynparza in combination with abiraterone and either prednisone or prednisolone is indicated for the:,? treatment of adult patients who have mcrpc with a deleterious or suspected deleterious brca mutation (germline or somatic). adenocarcinoma of the pancreas,lynparza is indicated as monotherapy for the:,? maintenance treatment of adult patients who have metastatic pancreatic adenocarcinoma with a deleterious or suspected deleterious gbrcam, which has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - talazoparib as tosylate - hard capsule - talazoparib as tosylate 0.25 mg - talazoparib - talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutated (gbrcam) human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - talazoparib as tosylate - hard capsule - talazoparib as tosylate 1 mg - talazoparib - talzenna is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutated (gbrcam) human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer.