Ifirmacombi
irbesartan / hydrochlorothiazide
Table of contents
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.
Authorisation details
Product details | |
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Name |
Ifirmacombi
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Agency product number |
EMEA/H/C/002302
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Hypertension
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Anatomical therapeutic chemical (ATC) code |
C09DA04
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Generic |
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 | |
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Marketing-authorisation holder |
Krka, d.d., Novo mesto
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
04/03/2011
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Contact address |
Product information
22/07/2020 Ifirmacombi - EMEA/H/C/002302 - IB/0026
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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
News
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17/05/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011