Bydureon (exenatide)
- Region
- 🇪🇺 EU
- Active substance
- exenatide
- Company
- AstraZeneca AB
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 14 Apr 2011
- EU approval
- Fri 17 Jun 2011
- Application
- EMEA/H/C/002020
- ATC
- A10BJ01
- Official record
- www.ema.europa.eu
Indication
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: 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Byetta Withdrawn · AstraZeneca AB
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.