🇪🇺 Irbesartan SR47436 in European Union

EMA authorised Irbesartan SR47436 on 26 August 1997

Marketing authorisation

EMA — authorised 26 August 1997

  • Application: EMEA/H/C/000141
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Aprovel
  • Indication: Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.
  • Status: approved

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Irbesartan SR47436 in other countries

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

Frequently asked questions

Is Irbesartan SR47436 approved in European Union?

Yes. EMA authorised it on 26 August 1997.

Who is the marketing authorisation holder for Irbesartan SR47436 in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.