🇪🇺 Renin-angiotensin system blockers in European Union

EMA authorised Renin-angiotensin system blockers on 26 August 1997

Marketing authorisations

EMA — authorised 26 August 1997

  • Application: EMEA/H/C/000142
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Karvea
  • 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

Read official source →

EMA — authorised 14 October 1998

  • Application: EMEA/H/C/000222
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: CoAprovel
  • Indication: Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
  • Status: approved

Read official source →

EMA — authorised 16 October 1998

  • Application: EMEA/H/C/000221
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Karvezide
  • Indication: Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
  • Status: approved

Read official source →

EMA — authorised 18 January 2007

  • Application: EMEA/H/C/000783
  • Marketing authorisation holder: sanofi-aventis groupe
  • Local brand name: Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
  • Indication: Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
  • Status: approved

Read official source →

EMA — authorised 19 January 2007

  • Application: EMEA/H/C/000786
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Irbesartan BMS
  • 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 (see section 5.1).
  • Status: withdrawn

Read official source →

EMA — authorised 19 January 2007

  • Application: EMEA/H/C/000784
  • Marketing authorisation holder: Bristol-Myers Squibb Pharma EEIG
  • Local brand name: Irbesartan Hydrochlorothiazide BMS
  • Indication: Treatment of essential hypertension.This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
  • Status: withdrawn

Read official source →

EMA — authorised 19 January 2007

  • Application: EMEA/H/C/000785
  • Marketing authorisation holder: Zentiva k.s.
  • Local brand name: Irbesartan Zentiva (previously Irbesartan Winthrop)
  • 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

Read official source →

EMA — authorised 1 December 2008

  • Application: EMEA/H/C/000962
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Ifirmasta (previously Irbesartan Krka)
  • 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

Read official source →

EMA — authorised 30 October 2009

  • Application: EMEA/H/C/001093
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Irbesartan Teva
  • 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

Read official source →

EMA — authorised 26 November 2009

  • Application: EMEA/H/C/001112
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Irbesartan/Hydrochlorothiazide Teva
  • Indication: Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
  • Status: approved

Read official source →

EMA — authorised 4 March 2011

  • Application: EMEA/H/C/002302
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Ifirmacombi
  • Indication: Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
  • Status: approved

Read official source →

EMA — authorised 13 April 2012

  • Application: EMEA/H/C/002510
  • Marketing authorisation holder: Pharmathen S.A.
  • Local brand name: Sabervel
  • Indication: Sabervel is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
  • Status: withdrawn

Read official source →

Other Cardiovascular approved in European Union

Frequently asked questions

Is Renin-angiotensin system blockers approved in European Union?

Yes. EMA authorised it on 26 August 1997; EMA authorised it on 14 October 1998; EMA authorised it on 16 October 1998.

Who is the marketing authorisation holder for Renin-angiotensin system blockers in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.