🇪🇺 meglitinides in European Union

EMA authorised meglitinides on 3 April 2001

Marketing authorisations

Application: EMEA/H/C/000383
Marketing authorisation holder: Novartis Europharm Ltd.
Local brand name: Trazec
Indication: Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Status: withdrawn

Application: EMEA/H/C/001067
Marketing authorisation holder: Teva Pharma B.V.
Local brand name: Repaglinide Teva
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. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Status: approved

Application: EMEA/H/C/001065
Marketing authorisation holder: Krka, d.d., Novo mesto
Local brand name: Enyglid
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. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Status: approved

Application: EMEA/H/C/001066
Marketing authorisation holder: Krka, d.d., Novo mesto
Local brand name: Repaglinide Krka
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.
Status: approved

Application: EMEA/H/C/002318
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Repaglinide Accord
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.
Status: approved

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Is meglitinides approved in European Union?

Yes. EMA authorised it on 3 April 2001; EMA authorised it on 28 June 2009; EMA authorised it on 13 October 2009.

Who is the marketing authorisation holder for meglitinides in European Union?

Novartis Europharm Ltd. holds the EU marketing authorisation.