Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
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.
Active Substances (2)
irbesartan
hydrochlorothiazide
Documents (15)
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...
September 29, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31
September 29, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi : EPAR - Scientific conclusions
May 23, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi : EPAR - Public assessment report
March 16, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ifirmacombi : EPAR - Summary for the public
March 16, 2011
OVERVIEW_DOCUMENT
Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation
May 23, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi : EPAR - Product information
March 16, 2011
DRUG_PRODUCT_INFORMATION
Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines
July 5, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Ifirmacombi
December 16, 2010
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ifirmacombi : EPAR - All Authorised presentations
March 16, 2011
AUTHORISED_PRESENTATIONS
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report
May 2, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines
March 2, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi : EPAR - Public assessment report
March 16, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation (archive)
November 14, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Ifirmacombi
December 16, 2010
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (8)
Question
What are the benefits and risks of Ifirmacombi?
Answer
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.
Question
How is Ifirmacombi used?
Answer
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.
Question
How does Ifirmacombi work?
Answer
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.
Question
Other information about Ifirmacombi
Answer
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.
Question
What is Ifirmacombi?
Answer
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.
Question
How has Ifirmacombi been studied?
Answer
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.
Question
Why has Ifirmacombi been approved?
Answer
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.
Question
What is Ifirmacombi used for?
Answer
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.