Irbesartan Hydrochlorothiazide BMS
irbesartan / hydrochlorothiazide
Table of contents
Overview
The marketing authorisation for Irbesartan Hydrochlorothiazide BMS has been withdrawn at the request of the marketing authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Irbesartan Hydrochlorothiazide BMS
|
| Agency product number |
EMEA/H/C/000784
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Hypertension
|
| Anatomical therapeutic chemical (ATC) code |
C09DA04
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
| Revision |
8
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/01/2007
|
| Contact address |
Plaza 254 |
Product information
09/10/2009 Irbesartan Hydrochlorothiazide BMS - EMEA/H/C/000784 - N/0030
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Agents acting on the renin-angiotensin system
Therapeutic 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).