Irbesartan BMS

RSS
Withdrawn

This medicine's authorisation has been withdrawn

irbesartan
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Irbesartan BMS has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: II/0018
07/04/2009
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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español (ES) (256.97 KB - PDF)

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čeština (CS) (272.25 KB - PDF)

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dansk (DA) (254.03 KB - PDF)

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slovenščina (SL) (301.48 KB - PDF)

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Suomi (FI) (258.8 KB - PDF)

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svenska (SV) (286.13 KB - PDF)

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Product details

Name of medicine
Irbesartan BMS
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic 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).

Authorisation details

EMA product number
EMEA/H/C/000786
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Marketing authorisation issued
19/01/2007
Revision
7

Assessment history

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