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

alnylam australia pty ltd - patisiran, quantity: 10 mg - injection, concentrated - excipient ingredients: peg2000-c-dmg; sodium chloride; dlin-mc3-dma; water for injections; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; cholesterol; distearoylphosphatidylcholine - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

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.

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.

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

medis pharma pty ltd - fentanyl, quantity: 16.5 mg - drug delivery system, transdermal - excipient ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - for the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. not for use in opioid-na?ve patients.

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

medis pharma pty ltd - fentanyl, quantity: 12.375 mg - drug delivery system, transdermal - excipient ingredients: polypropylene; polyethylene terephthalate; titanium dioxide; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - for the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. not for use in opioid-na?ve patients.

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

medis pharma pty ltd - fentanyl, quantity: 8.25 mg - drug delivery system, transdermal - excipient ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - for the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. not for use in opioid-na?ve patients.

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

medis pharma pty ltd - fentanyl, quantity: 4.125 mg - drug delivery system, transdermal - excipient ingredients: polyethylene terephthalate; titanium dioxide; polypropylene; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - for the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. not for use in opioid-na?ve patients.

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

medis pharma pty ltd - fentanyl, quantity: 2.063 mg - drug delivery system, transdermal - excipient ingredients: polypropylene; polyethylene terephthalate; titanium dioxide; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane - for the management of pain associated with cancer, palliative care, and other conditions in patients where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? severe enough to require daily, continuous, long term opioid treatment. not for use in opioid-na?ve patients.

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

astrazeneca pty ltd - olaparib, quantity: 50 mg - capsule - excipient ingredients: gellan gum; hypromellose; titanium dioxide; potassium acetate; lauroyl macrogolglycerides; iron oxide black; shellac - olaparib is indicated as monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed brca-mutated (germline or somatic) high grade serous 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.

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

alphapharm pty ltd - fentanyl, quantity: 2.55 mg - drug delivery system, transdermal - excipient ingredients: dimeticone 360; polyethylene terephthalate; polyvinylidene flouride; methylated trimethylated silica; heptane; titanium dioxide; strong ammonia solution; industrial methylated spirit; potable water; styrene/acrylates copolymer; trolamine; polyethylene; polytef; dimeticone 350; docusate sodium; propylene glycol; purified water; acrylates copolymer; methoxyisopropyl acetate; 2-ethylhexyl acrylate; ethyl acetate; polyisocyanate; 4,4'-diphenylmethane diisocyanate; silane; polypropylene; ethylene/propylene copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; tris(2,4-ditert-butyphenyl) phosphite; calcium stearate; aluminium magnesium hydroxide carbonate; perflouropropylene/vinylidene diflouride copolymer; 1,3,5-trimethyl-2,4,6-tris(3,5-ditert-butyl-4-hydroxybenzyl)benzene; aluminium calcium sodium silicate; octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; iron oxide red; pigment yellow 119; zinc stearate - for the management of pain associated with cancer, palliative cancer and other conditions in patients where: - other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and - the pain is opioid-responsive, and - severe enough to require daily, continuous long term opioid treatment. not for use in opioid-naive patients.