Repaglinide Accord (repaglinide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- repaglinide
- Company
- Accord Healthcare S.L.U.
- Status
- Withdrawn
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Thu 20 Oct 2011
- EU approval
- Thu 22 Dec 2011
- Designations
- Generic
- Application
- EMEA/H/C/002318
- ATC
- A10BX02
- Official record
- www.ema.europa.eu
Indication
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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- 🇪🇺 Repaglinide Teva Authorised · Teva Pharma B.V.
- 🇪🇺 Prandin Authorised · Novo Nordisk A/S
- 🇪🇺 NovoNorm Authorised · Novo Nordisk A/S
- 🇪🇺 Repaglinide Sun Application withdrawn · Sun Pharmaceutical Industries B.V.
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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.