Ifirmacombi

Authorised

This medicine is authorised for use in the European Union

irbesartan / hydrochlorothiazide

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.

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.

Ifirmacombi : EPAR - Summary for the public

Reference Number: EMA/187625/2011

Product information

Ifirmacombi : EPAR - Product information

Ifirmacombi : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ifirmacombi
• Active substance:
  • irbesartan
  • hydrochlorothiazide
• International non-proprietary name (INN) or common name:
  • irbesartan
  • hydrochlorothiazide
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09DA04

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002302
• 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.

• Marketing authorisation holder:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Marketing authorisation issued:
  04/03/2011
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Ifirmacombi : EPAR - Procedural steps taken and scientific information after authorisation

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines

Adopted

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines

AdoptedReference Number: EMA/47245/2021

Ifirmacombi : EPAR - Scientific conclusions

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report

AdoptedReference Number: EMA/217823/2019

Ifirmacombi-H-C-2302-A31-09 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

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 recomme...

Initial marketing authorisation documents

Ifirmacombi : EPAR - Public assessment report

AdoptedReference Number: EMA/99460/2011

CHMP summary of positive opinion for Ifirmacombi

AdoptedReference Number: EMA/646092/2010