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Repaglinide Krka (repaglinide)

Generic
Region
🇪🇺 EU
Active substance
repaglinide
Company
KRKA tovarna zdravil d.d. Novo mesto
Status
Authorised
Therapeutic area
Diabetes Mellitus, Type 2
CHMP opinion
Thu 23 Jul 2009
EU approval
Tue 03 Nov 2009
Designations
Generic
Application
EMEA/H/C/001066
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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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.