New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - olaparib 100mg;   - film coated tablet - 100 mg - active: olaparib 100mg   excipient: colloidal silicon dioxide copovidone hypromellose iron oxide yellow macrogol 400 mannitol purified water sodium stearyl fumarate titanium dioxide - lynparza is indicated as monotherapy for the 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 is indicated as monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced brca-mutated 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. 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - olaparib 150mg;   - film coated tablet - 150 mg - active: olaparib 150mg   excipient: colloidal silicon dioxide copovidone hypromellose iron oxide black iron oxide yellow macrogol 400 mannitol purified water sodium stearyl fumarate titanium dioxide - lynparza is indicated as monotherapy for the 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 is indicated as monotherapy for the maintenance treatment of adult patients with newly diagnosed advanced brca-mutated 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. 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.

Israel - English - Ministry of Health

astra zeneca (israel) ltd - olaparib - hard capsule - olaparib 50 mg - olaparib - lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed brca-mutated (germline and/or somatic) high grade serous epithelial ovarian cancer, (including fallopian tube, or primary peritoneal) cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

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.

Malta - English - Medicines Authority

dompe farmaceutici spa via san martino 12, 20122, milan, italy - ketoprofen lysine - cutaneous foam - ketoprofen lysine 15 % (w/v) - topical products for joint and muscular pain

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovarian neoplasms - antineoplastic agents - ovarian cancerlynparza 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 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 5.1).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 and 5.1).monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). patients with hormone receptor (hr)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.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 5.1).

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - talazoparib tosylate eqv talazoparib - capsule - talazoparib tosylate eqv talazoparib 0.25 mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - talazoparib tosylate eqv talazoparib - capsule - talazoparib tosylate eqv talazoparib 1 mg

Malta - English - Medicines Authority

dompe farmaceutici spa via san martino 12, 20122, milan, italy - ketoprofen lysine - gel - ketoprofen lysine 5 % (w/w) - topical products for joint and muscular pain

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - olaparib 50mg - capsule - 50 mg - active: olaparib 50mg excipient: gellan gum hypromellose lauroyl macrogol-32 glycerides iron oxide black potassium acetate shellac titanium dioxide - lynparza is indicated as monotherapy for the maintenance treatment of adult 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.