Индия - английски - Central Drugs Standard Control Organization

eli lilly - exenatide - 10mcg( mannitol,glacial acetic acid,sod.acet.) - pfs

Индия - английски - Central Drugs Standard Control Organization

eli lilly - exenatide - 5mcg( mannitol,glacial acetic acid,sod.acet.) - pfs

Индия - английски - Central Drugs Standard Control Organization

sun - exenatide - inj - 250mcg/ml - 1

Индия - английски - Central Drugs Standard Control Organization

natco - exenatide - 5mcg(multidose vial,m-cresol 0.2%w/v) - vial

Нова Зеландия - английски - 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.

Нова Зеландия - английски - 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).

Нова Зеландия - английски - 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).

Нова Зеландия - английски - 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).

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - dulaglutide - solution for injection - 1.5mg/1ml

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

eli lilly and company ltd - dulaglutide - solution for injection - 3mg/1ml