🇪🇺 placebo/valsartan in European Union

EMA authorised placebo/valsartan on 15 October 2009

Marketing authorisations

EMA — authorised 15 October 2009

  • Application: EMEA/H/C/001068
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Exforge HCT
  • Indication: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
  • Status: approved

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EMA — authorised 3 November 2009

  • Application: EMEA/H/C/001160
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Dafiro HCT
  • Indication: Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
  • Status: approved

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Other Cardiovascular approved in European Union

Frequently asked questions

Is placebo/valsartan approved in European Union?

Yes. EMA authorised it on 15 October 2009; EMA authorised it on 3 November 2009.

Who is the marketing authorisation holder for placebo/valsartan in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.