Ifirmacombi

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irbesartan / hydrochlorothiazide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ifirmacombi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ifirmacombi.

This EPAR was last updated on 23/05/2019

Authorisation details

Product details
Name
Ifirmacombi
Agency product number
EMEA/H/C/002302
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
irbesartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA04
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Krka, d.d., Novo mesto
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
04/03/2011
Contact address
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

09/04/2019 Ifirmacombi - EMEA/H/C/002302 - A31/0020

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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