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

astrazeneca pty ltd - exenatide -

Israel - English - Ministry of Health

astrazeneca (israel) ltd - exenatide - powder and solvent for suspension for injection - exenatide 2 mg - exenatide - 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 - 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 .

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

astrazeneca pty ltd - exenatide -

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - exenatide 250 µg/ml;   - solution for injection - 10µg/40µl - active: exenatide 250 µg/ml   excipient: glacial acetic acid mannitol metacresol sodium acetate trihydrate water for injection - adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic control. to improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin with or without metformin and/or a thiozolidinedione.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - exenatide 250 µg/ml;   - solution for injection - 5µg/20µl - active: exenatide 250 µg/ml   excipient: glacial acetic acid mannitol metacresol sodium acetate trihydrate water for injection - adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic control. to improve glycaemic control in patients with type 2 diabetes mellitus in combination with a basal insulin with or without metformin and/or a thiozolidinedione.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - exenatide - diabetes mellitus, type 2 - drugs used in diabetes - byetta is indicated for treatment of type-2 diabetes mellitus in combination with:metformin;sulphonylureas;thiazolidinediones;metformin and a sulphonylurea;metformin and a thiazolidinedione;in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and / or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - exenatide - diabetes mellitus, type 2 - drugs used in diabetes - 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 when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control (see section 4.4, 4.5 and 5.1 for available data on different combinations).bydureon is indicated for treatment of type 2 diabetes mellitus in combination with:metforminsulphonylureathiazolidinedionemetformin and sulphonylureametformin and thiazolidinedionein adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - exenatide 2mg;  ;   - injection with diluent - 2 mg - active: exenatide 2mg     excipient: 5050 dl 4ap polymer (poly(d,l-lactide-co-glycolide)) sucrose carmellose sodium dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride water for injection carmellose sodium dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injection - bydureon is indicated for treatment of type 2 diabetes mellitus in combination with · metformin · sulphonylurea · thiazolidinedione · metformin and sulphonylurea · metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Canada - English - Health Canada

astrazeneca canada inc - exenatide - solution - 5mcg - exenatide 5mcg - incretin mimetics