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

astrazeneca pty ltd - water for injections -

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

astrazeneca pty ltd - sodium chloride -

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

astrazeneca pty ltd - sodium chloride -

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - chadox1-s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 5.0 x 10^8 infectious units per ml);  ;  ;   - solution for injection - active: chadox1-s 100 gvp/ml (gvp = giga viral particles; equivalent to not less than to 5.0 x 10^8 infectious units per ml)       excipient: disodium edetate dihydrate ethanol histidine histidine hydrochloride monohydrate magnesium chloride hexahydrate polysorbate 80 sodium chloride sucrose water for injection - covid-19 vaccine astrazeneca is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. the use of this vaccine should be in accordance with official recommendations.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - candesartan cilexetil 32mg;  ;   - tablet - 32 mg - active: candesartan cilexetil 32mg     excipient: carmellose calcium ferrous oxide hyprolose lactose monohydrate macrogol 8000 magnesium stearate maize starch - treatment of hypertension

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg;   - film coated tablet - 10 mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapaglifozin 10mg   excipient: colloidal silicon dioxide crospovidone opadry ii yellow lactose magnesium stearate microcrystalline cellulose - monotherapy forxiga is indicated in adults with type 2 diabetes mellitus as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated. initial combination forxiga is indicated in adults with type 2 diabetes mellitus as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy. add-on combination forxiga is indicated in adult patients with type 2 diabetes mellitus in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise do not provide adequate glycaemic control. prevention of hospitalisation for heart failure forxiga 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. prevention of new or worsening nephropathy forxiga 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.

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg - film coated tablet - 2.5 mg - active: saxagliptin hydrochloride 2.98mg equivalent to saxagliptin 2.5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-10619 opadry ii yellow 85f92209 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg - film coated tablet - 5 mg - active: saxagliptin hydrochloride 5.95mg equivalent to saxagliptin 5 mg excipient: croscarmellose sodium hydrochloric acid lactose monohydrate magnesium stearate microcrystalline cellulose opacode blue s-1-4118 opadry pink 85f14452 opadry white 85f18422 purified water - onglyza is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 1000mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/1000mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 1000mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose lactose magnesium stearate microcrystalline cellulose opadry yellow 85f12372 - 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).

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

astrazeneca limited - dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg;  ; metformin hydrochloride 500mg (with 0.5% magnesium stearate);   - modified release tablet - 10mg/500mg - active: dapagliflozin propanediol monohydrate 12.3mg equivalent to dapagliflozin 10 mg   metformin hydrochloride 500mg (with 0.5% magnesium stearate)   excipient: carmellose sodium colloidal silicon dioxide crospovidone hypromellose microcrystalline cellulose (ph302) hypromellose (2910) lactose magnesium stearate microcrystalline cellulose opadry pink 85f94333 - 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).