Ifirmacombi

irbesartan / hydrochlorothiazide

Overview
Authorisation details
Product information
Assessment history

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.

: Ifirmacombi is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as tablets (150 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide; 300 mg irbesartan and 12.5 mg hydrochlorothiazide).
Ifirmacombi is a ‘generic medicine’. This means that Ifirmacombi is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CoAprovel.

: Ifirmacombi is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: The dose of Ifirmacombi to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before. Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended. Ifirmacombi may be added to other treatments for hypertension.

: Ifirmacombi contains two active substances, irbesartan and hydrochlorothiazide.
Irbesartan is an ‘angiotensin-II-receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure.
The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.

: Because Ifirmacombi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, CoAprovel. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

: Because Ifirmacombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The CHMP concluded that, in accordance with EU requirements, Ifirmacombi has been shown to have comparable quality and to be bioequivalent to CoAprovel. Therefore, the CHMP’s view was that, as for CoAprovel, the benefit outweighs the identified risk. The Committee recommended that Ifirmacombi be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Ifirmacombi on 4 March 2011.
For more information about treatment with Ifirmacombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Ifirmacombi : EPAR - Summary for the public (PDF/74.29 KB)

First published: 17/03/2011
Last updated: 22/01/2016
EMA/187625/2011
- Bulgarian
  (PDF/100.98 KB)
- Croatian
  (PDF/89.37 KB)
- Czech
  (PDF/97.73 KB)
- Danish
  (PDF/73.96 KB)
- Dutch
  (PDF/74.53 KB)
- Estonian
  (PDF/73.09 KB)
- Finnish
  (PDF/73.93 KB)
- French
  (PDF/78.04 KB)
- German
  (PDF/74.87 KB)
- Greek
  (PDF/102.61 KB)
- Hungarian
  (PDF/92.39 KB)
- Italian
  (PDF/73.69 KB)
- Latvian
  (PDF/101.39 KB)
- Lithuanian
  (PDF/95.67 KB)
- Maltese
  (PDF/98.26 KB)
- Polish
  (PDF/98.43 KB)
- Portuguese
  (PDF/74.41 KB)
- Romanian
  (PDF/94.18 KB)
- Slovak
  (PDF/97.24 KB)
- Slovenian
  (PDF/88.7 KB)
- Spanish
  (PDF/74.3 KB)
- Swedish
  (PDF/73.88 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 25/11/2019

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
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
Marketing-authorisation holder	Krka, d.d., Novo mesto
Revision	10
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

07/11/2019 Ifirmacombi - EMEA/H/C/002302 - IB/0024

List item

Ifirmacombi : EPAR - Product Information (PDF/244.06 KB)

First published: 17/03/2011
Last updated: 25/11/2019
- Bulgarian
  (PDF/269.99 KB)
- Croatian
  (PDF/234.48 KB)
- Czech
  (PDF/242.86 KB)
- Danish
  (PDF/299.02 KB)
- Dutch
  (PDF/253.21 KB)
- Estonian
  (PDF/287.26 KB)
- Finnish
  (PDF/257.79 KB)
- French
  (PDF/260.37 KB)
- German
  (PDF/257.63 KB)
- Greek
  (PDF/290.11 KB)
- Hungarian
  (PDF/258.61 KB)
- Icelandic
  (PDF/245.3 KB)
- Italian
  (PDF/254.29 KB)
- Latvian
  (PDF/255.65 KB)
- Lithuanian
  (PDF/250.6 KB)
- Maltese
  (PDF/299.62 KB)
- Norwegian
  (PDF/253.89 KB)
- Polish
  (PDF/274.95 KB)
- Portuguese
  (PDF/252.5 KB)
- Romanian
  (PDF/253.97 KB)
- Slovak
  (PDF/254.82 KB)
- Slovenian
  (PDF/245.37 KB)
- Spanish
  (PDF/302.86 KB)
- Swedish
  (PDF/240.2 KB)

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.

List item

Ifirmacombi : EPAR - All Authorised presentations (PDF/42.46 KB)

First published: 17/03/2011
Last updated: 17/03/2011
- Bulgarian
  (PDF/78.12 KB)
- Czech
  (PDF/56.72 KB)
- Danish
  (PDF/43.58 KB)
- Dutch
  (PDF/43.36 KB)
- Estonian
  (PDF/44.26 KB)
- Finnish
  (PDF/43.78 KB)
- French
  (PDF/43.85 KB)
- German
  (PDF/44.48 KB)
- Greek
  (PDF/77.28 KB)
- Hungarian
  (PDF/74.61 KB)
- Icelandic
  (PDF/43.44 KB)
- Italian
  (PDF/43 KB)
- Latvian
  (PDF/74.98 KB)
- Lithuanian
  (PDF/75.23 KB)
- Maltese
  (PDF/72.93 KB)
- Norwegian
  (PDF/43.72 KB)
- Polish
  (PDF/57.17 KB)
- Portuguese
  (PDF/43.89 KB)
- Romanian
  (PDF/72.58 KB)
- Slovak
  (PDF/57.08 KB)
- Slovenian
  (PDF/43.13 KB)
- Spanish
  (PDF/43.87 KB)
- Swedish
  (PDF/43.55 KB)

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

List item

Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/115.09 KB)

First published: 14/11/2012
Last updated: 25/11/2019
List item

Ifirmacombi : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 23/05/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
  (PDF/96.12 KB)
- Dutch
  (PDF/99.3 KB)
- Estonian
  (PDF/94.4 KB)
- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
  (PDF/100.2 KB)
- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
  (PDF/130.84 KB)
- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
  (PDF/128.25 KB)
- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
List item

Sartans Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019
List item

Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 30/09/2014
Last updated: 30/09/2014
EMA/PRAC/294920/2014
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Ifirmacombi-H-C-2302-A31-09 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recomme... (PDF/48.81 KB)

First published: 30/09/2014
Last updated: 30/09/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
  (PDF/49.82 KB)
- Estonian
  (PDF/50.6 KB)
- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
  (PDF/53.54 KB)
- Greek
  (PDF/89.54 KB)
- Hungarian
  (PDF/68.7 KB)
- Italian
  (PDF/51.13 KB)
- Latvian
  (PDF/81.63 KB)
- Lithuanian
  (PDF/82.54 KB)
- Maltese
  (PDF/84.23 KB)
- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
  (PDF/81.5 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)

Ifirmacombi

Table of contents

Overview

Ifirmacombi : EPAR - Summary for the public (PDF/74.29 KB)

Authorisation details

Product information

Ifirmacombi : EPAR - Product Information (PDF/244.06 KB)

Contents

Ifirmacombi : EPAR - All Authorised presentations (PDF/42.46 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/115.09 KB)

Ifirmacombi : EPAR - Scientific conclusions (PDF/99.42 KB)

Sartans Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Ifirmacombi-H-C-2302-A31-09 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recomme... (PDF/48.81 KB)

Initial marketing-authorisation documents

Ifirmacombi : EPAR - Public assessment report (PDF/525.5 KB)

CHMP summary of positive opinion for Ifirmacombi (PDF/50.47 KB)

News

More information on Ifirmacombi

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

Questions and answers on generic medicines (PDF/66.45 KB)

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Ifirmacombi

Table of contents

Overview

Ifirmacombi : EPAR - Summary for the public (PDF/74.29 KB)

Authorisation details

Product information

Ifirmacombi : EPAR - Product Information (PDF/244.06 KB)

Contents

Ifirmacombi : EPAR - All Authorised presentations (PDF/42.46 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/115.09 KB)

Ifirmacombi : EPAR - Scientific conclusions (PDF/99.42 KB)

Sartans Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Ifirmacombi-H-C-2302-A31-09 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recomme... (PDF/48.81 KB)

Initial marketing-authorisation documents

Ifirmacombi : EPAR - Public assessment report (PDF/525.5 KB)

CHMP summary of positive opinion for Ifirmacombi (PDF/50.47 KB)

News

More information on Ifirmacombi

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

Questions and answers on generic medicines (PDF/66.45 KB)

Related content

How useful was this page?