Ifirmacombi

irbesartan / hydrochlorothiazide

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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.

What is 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.

What is Ifirmacombi used for?

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.

How is Ifirmacombi used?

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.

How does Ifirmacombi work?

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.

How has Ifirmacombi been studied?

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.

What are the benefits and risks of Ifirmacombi?

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.

Why has Ifirmacombi been approved?

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.

Other information about Ifirmacombi

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.

Name Language First published Last updated
Ifirmacombi : EPAR - Summary for the public BG = bălgarski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public ES = español 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public CS = čeština 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public DA = dansk 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public DE = Deutsch 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public ET = eesti keel 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public EL = elliniká 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public EN = English 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public FR = français 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public IT = italiano 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public LV = latviešu valoda 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public LT = lietuvių kalba 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public HU = magyar 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public MT = Malti 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public NL = Nederlands 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public PL = polski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public PT = português 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public RO = română 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public SK = slovenčina 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public SL = slovenščina 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public FI = suomi 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public SV = svenska 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Summary for the public HR = Hrvatski 17/03/2011 22/01/2016

This EPAR was last updated on 22/01/2016 .

Authorisation details

Product details

Product details for Ifirmacombi
NameIfirmacombi
Agency product numberEMEA/H/C/002302
Active substance

irbesartan / hydrochlorothiazide

International non-proprietary name (INN) or common name

irbesartan / hydrochlorothiazide

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DA04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Ifirmacombi
Marketing-authorisation holder

Krka, d.d., Novo mesto

Revision4
Date of issue of marketing authorisation valid throughout the European Union04/03/2011

Contact address:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

19/11/2015  Ifirmacombi -EMEA/H/C/002302 -R/0015

Name Language First published Last updated
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016
Ifirmacombi : EPAR - Product Information HR = Hrvatski 17/03/2011 22/01/2016

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.


Name Language First published Last updated
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  
Ifirmacombi : EPAR - All Authorised presentations HR = Hrvatski 17/03/2011  

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

Name Language First published Last updated
Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 14/11/2012 22/01/2016
Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31 HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  
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 recommendation HR = Hrvatski 30/09/2014  

Initial marketing-authorisation documents

Name Language First published Last updated
Ifirmacombi : EPAR - Public assessment report HR = Hrvatski 17/03/2011  
CHMP summary of positive opinion for Ifirmacombi HR = Hrvatski 17/12/2010  

Authorised

This medicine is approved for use in the European Union

More information on Ifirmacombi