Bangladesh - English - DGDA (Directorate General of Drug Administration)

astra biopharmaceuticals ltd. - nicotinamide + pyridoxine hydrochloride + riboflavin + vitamin b1 + zinc - tablet - 20 mg + 2 mg + 2.75 mg + 5 mg + 10 mg

Israel - English - Ministry of Health

astrazeneca (israel) ltd - exenatide - powder and solvent for suspension for injection - exenatide 2 mg - exenatide - bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control .

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.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

astrazeneca uk ltd - acalabrutinib - capsule - 100mg

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

mcpherson's consumer products pty ltd - codonopsis pilosula, quantity: 150 mg (equivalent: codonopsis pilosula, qty 750 mg); glycyrrhiza uralensis, quantity: 20 mg (equivalent: glycyrrhiza uralensis, qty 100 mg); ganoderma lucidum, quantity: 75 mg (equivalent: ganoderma lucidum, qty 750 mg); schisandra chinensis, quantity: 50 mg (equivalent: schisandra chinensis, qty 500 mg); eleutherococcus senticosus, quantity: 33.33 mg (equivalent: eleutherococcus senticosus, qty 500 mg); atractylodes macrocephala, quantity: 150 mg (equivalent: atractylodes macrocephala, qty 750 mg); astragalus membranaceus, quantity: 200 mg (equivalent: astragalus membranaceus, qty 3 g); ligustrum lucidum, quantity: 87.5 mg (equivalent: ligustrum lucidum, qty 875 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; colloidal anhydrous silica; maltodextrin; microcrystalline cellulose; calcium hydrogen phosphate; magnesium stearate; carnauba wax; macrogol 8000; hypromellose - traditionally used in chinese medicine to stabilise exterior ; traditionally used in chinese medicine to tonify/nourish/strengthen/replenish qi ; traditionally used in chinese medicine to tonify/nourish/strengthen/replenish/fortify lungs/lung-qi ; traditionally used in chinese medicine to support protective qi ; traditionally used in chinese medicine to relieve feelings of general malaise/general debility ; traditionally used in chinese medicine to helps enhance/promote/increase vitality ; traditionally used in chinese medicine to relieve weariness/tiredness/fatigue/feeling of weakness ; traditionally used in chinese medicine to restorative tonic ; traditionally used in western herbal medicine to enhance/improve/promote immune defence/immunity ; traditionally used in chinese medicine to enhance/improve/promote immune defence/immunity ; traditionally used in western herbal medicine to helps enhance/improve/promote immune system function ; traditionally used in western herbal medicine to maintain/support immune system to fight illness ; traditionally used in western herbal medicine to helps stimulate a healthy immune system response ; traditionally used in chinese medicine to adaptogen/help body adapt to stress ; traditionally used in chinese medicine to helps reduce occurrence of common colds

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

mcpherson's consumer products pty ltd - ganoderma lucidum, quantity: 75 mg (equivalent: ganoderma lucidum, qty 750 mg); codonopsis pilosula, quantity: 150 mg (equivalent: codonopsis pilosula, qty 750 mg); atractylodes macrocephala, quantity: 150 mg (equivalent: atractylodes macrocephala, qty 750 mg); astragalus membranaceus, quantity: 200 mg (equivalent: astragalus membranaceus, qty 3 g); glycyrrhiza uralensis, quantity: 20 mg (equivalent: glycyrrhiza uralensis, qty 100 mg); ligustrum lucidum, quantity: 87.5 mg (equivalent: ligustrum lucidum, qty 875 mg); schisandra chinensis, quantity: 50 mg (equivalent: schisandra chinensis, qty 500 mg); eleutherococcus senticosus, quantity: 33.33 mg (equivalent: eleutherococcus senticosus, qty 500 mg) - tablet, film coated - excipient ingredients: maltodextrin; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; croscarmellose sodium; carnauba wax; calcium hydrogen phosphate; macrogol 8000; hypromellose - traditionally used in chinese medicine to stabilise exterior ; traditionally used in chinese medicine to tonify/nourish/strengthen/replenish qi ; traditionally used in chinese medicine to tonify/nourish/strengthen/replenish/fortify lungs/lung-qi ; traditionally used in chinese medicine to support protective qi ; traditionally used in chinese medicine to relieve feelings of general malaise/general debility ; traditionally used in chinese medicine to helps enhance/promote/increase vitality ; traditionally used in chinese medicine to relieve weariness/tiredness/fatigue/feeling of weakness ; traditionally used in chinese medicine to restorative tonic ; traditionally used in western herbal medicine to enhance/improve/promote immune defence/immunity ; traditionally used in chinese medicine to enhance/improve/promote immune defence/immunity ; traditionally used in western herbal medicine to helps enhance/improve/promote immune system function ; traditionally used in western herbal medicine to maintain/support immune system to fight illness ; traditionally used in western herbal medicine to helps stimulate a healthy immune system response ; traditionally used in chinese medicine to adaptogen/help body adapt to stress ; traditionally used in chinese medicine to helps reduce occurrence of common colds

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astramern sdn. bhd. - astragalus membranaceus; oryza sativa; zingiber officinale; glycyrrhiza glabra -