New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 5mg/1000mg - active: dapagliflozin propanediol monohydrate 6.15mg equivalent to dapagliflozin 5 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose calcium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry pink 85f94592 - glycaemic control xigduo xr is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control when treatment with both dapagliflozin and metformin is appropriate (see sections 5.1 and 4.4 for available data on the combination therapy). prevention of hospitalisation for heart failure dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalisation for heart failure (see section 5.1 pharmacodynamic properties – clinical efficacy and safety). prevention of new or worsening nephropathy dapagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease for the prevention of new or worsening nephropathy (see section 5.1 pharmacodynamic properties – clinical efficacy and safety).

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - lesinurad 200 mg - film coated tablet - 200 mg

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - pancuronium bromide 2 mg/ml - solution for injection - 4 mg/2ml - active: pancuronium bromide 2 mg/ml excipient: acetic acid sodium acetate trihydrate sodium chloride sodium hydroxide water for injection - an adjunct to surgical anaesthesia to induce skeletal muscle relaxation to facilitate operative manipulations. the necessary conditions for intubation can be achieved with pancuronium alone or following suxamethonium. to promote mechanical ventilation by reducing or eliminating spontaneous breathing effort in intensive care patients.

Den europeiske union - engelsk - EMA (European Medicines Agency)

astrazeneca ab - reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h5n1) strain - influenza, human - vaccines - prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age.pandemic influenza vaccine h5n1 astrazeneca should be used in accordance with official guidance

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

astrazeneca pty ltd - chadox1-s, quantity: 100000000000 vp/ml - injection, solution - excipient ingredients: histidine; magnesium chloride hexahydrate; sucrose; disodium edetate; polysorbate 80; sodium chloride; histidine hydrochloride monohydrate; ethanol absolute; water for injections - vaxzevria has provisional approval for the indication:,active immunisation of individuals greater than or equal to 18 years old for the prevention of coronavirus disease 2019 (covid-19) caused by sars-cov-2.,the use of this vaccine should be in accordance with official recommendations.,the decision has been made on the basis of short term efficacy and safety data. continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

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

astrazeneca pty ltd - goserelin, quantity: 3.6 mg - implant - excipient ingredients: polyglactin - prostate cancer: palliative treatment of metastatic or locally advanced prostate cancer, where suitable for hormonal manipulation. adjuvant and neo-adjuvant therapy in combination with radiotherapy for the management of locally advanced prostate cancer in men suitable for hormonal manipulation. breast cancer: treatment of advanced breast cancer (t3b, t4 or any t with n2, 3 or m plus) in premenopausal women suitable for hormonal manipulation. adjuvant therapy in early breast cancer, in pre- and perimenopausal women suitable for hormonal manipulation. endometriosis: in the management of visually proven endometriosis to reduce symptoms including pain and the size and number of endometrial lesions. uterine fibroids: in the management of fibroids, astrazeneca goserelin shrinks the lesions and reduces the symptoms, including pain. astrazeneca goserelin also increases the haemoglobin concentration and haematocrit in women with anaemia attributable to menorrhagia. it is used as an adjunct to surgery to facilitate the operative technique and reduce operativeblood loss. endometrial thinning: use as an endometrial thinning agent prior to endometrial ablation. assisted reproduction: pituitary down regulation in preparation for controlled ovarian superstimulation.

New Zealand - engelsk - 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.

New Zealand - engelsk - 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 - engelsk - 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.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

astrazeneca limited - candesartan cilexetil 16mg;  ;   - tablet - 16 mg - active: candesartan cilexetil 16mg     excipient: carmellose calcium ferrous oxide hyprolose lactose monohydrate macrogol 8000 magnesium stearate maize starch purified water - treatment of hypertension