🇪🇺 Prandin in European Union

EMA authorised Prandin on 29 January 2001

Marketing authorisations

EMA — authorised 29 January 2001

  • Application: EMEA/H/C/000362
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Prandin
  • 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

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EMA — authorised 20 October 2008

  • Status: approved

Prandin in other countries

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

Other Metabolic approved in European Union

Frequently asked questions

Is Prandin approved in European Union?

Yes. EMA authorised it on 29 January 2001; EMA authorised it on 20 October 2008.

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

Novo Nordisk A/S holds the EU marketing authorisation.