Eperzan (albiglutide)
- Region
- 🇪🇺 EU
- Active substance
- albiglutide
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Wed 22 Jan 2014
- EU approval
- Thu 20 Mar 2014
- Application
- EMEA/H/C/002735
- ATC
- A10BJ04
- Official record
- www.ema.europa.eu
Indication
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
Regulatory milestones
No milestones recorded in the last year.
Follow Eperzan
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.