Ifirmasta (previously Irbesartan Krka)

Authorised

This medicine is authorised for use in the European Union

irbesartan

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Ifirmasta?

Ifirmasta is a medicine that contains the active substance irbesartan. It is available as tablets (75, 150 and 300 mg).

Ifirmasta is a ‘generic medicine’. This means that Ifirmasta is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aprovel.

What is Ifirmasta used for?

Ifirmasta is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.

The medicine can only be obtained with a prescription.

How is Ifirmasta used?

The usual recommended dose of Ifirmasta is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.

In patients with hypertension and type 2 diabetes, Ifirmasta is added to some other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

How does Ifirmasta work?

The active substance in Ifirmasta, 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. This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.

How has Ifirmasta been studied?

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

What are the benefit and risk of Ifirmasta?

Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Ifirmasta been approved?

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

Other information about Ifirmasta

The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008. The name of the medicine was changed to Ifirmasta on 24 September 2009.

For more information about treatment with Ifirmasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Ifirmasta : EPAR - Summary for the public

Product information

Ifirmasta : EPAR - Product Information

Latest procedure affecting product information: IB/0025/G

30/06/2021

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Ifirmasta : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ifirmasta (previously Irbesartan Krka)
• Active substance:
  irbesartan hydrochloride
• International non-proprietary name (INN) or common name:
  irbesartan
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09CA04

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

Authorisation details

• EMA product number:
  EMEA/H/C/000962
• 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

• Opinion adopted:
  25/09/2008
• Marketing authorisation issued:
  01/12/2008
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Ifirmasta : 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

Ifirmasta-H-C-962-A31-0018 : EPAR - Scientific conclusions

Ifirmasta (previously Irbesartan Krka)-H-C-962-A31-0010 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the diffe...

Ifirmasta (previously Irbesartan Krka)-H-C-962-A31-0010 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

Initial marketing authorisation documents

Ifirmasta : EPAR - Public assessment report