Irbesartan Teva

irbesartan

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). 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).

: Irbesartan Teva is a medicine that contains the active substance irbesartan. It is available as white tablets (75, 150 and 300 mg).
Irbesartan Teva is a ‘generic medicine’. This means that Irbesartan Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aprovel.

: Irbesartan Teva is used in patients who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). Irbesartan Teva is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
The medicine can only be obtained with a prescription.

: Irbesartan Teva is taken by mouth, with or without food. The usual recommended dose 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, Irbesartan Teva is added to other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

: The active substance in Irbesartan Teva, 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 risks associated with high blood pressure, such as having a stroke.

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

: Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.

: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Teva 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 Irbesartan Teva be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009.

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Irbesartan Teva : EPAR - Summary for the public (PDF/43.36 KB)

First published: 16/11/2009
Last updated: 16/11/2009
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- Romanian
  (PDF/148.89 KB)
- Slovak
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- Slovenian
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- Spanish
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- Swedish
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This EPAR was last updated on 05/09/2023

Authorisation details

Product details
Name	Irbesartan Teva
Agency product number	EMEA/H/C/001093
Active substance	irbesartan
International non-proprietary name (INN) or common name	irbesartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09CA04
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	Teva B.V.
Revision	16
Date of issue of marketing authorisation valid throughout the European Union	30/10/2009
Contact address	Swensweg 5 2031GA Haarlem The Netherlands

Product information

01/09/2023 Irbesartan Teva - EMEA/H/C/001093 - IB/0047

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Irbesartan Teva : EPAR - Product Information (PDF/497.85 KB) (updated)

First published: 16/11/2009
Last updated: 05/09/2023
- Bulgarian
  (PDF/599.31 KB)
- Croatian
  (PDF/519.68 KB)
- Czech
  (PDF/539.16 KB)
- Danish
  (PDF/504.19 KB)
- Dutch
  (PDF/487.76 KB)
- Estonian
  (PDF/453.24 KB)
- Finnish
  (PDF/482.92 KB)
- French
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- German
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- Greek
  (PDF/579.54 KB)
- Hungarian
  (PDF/561.28 KB)
- Icelandic
  (PDF/508.01 KB)
- Italian
  (PDF/493.07 KB)
- Latvian
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- Lithuanian
  (PDF/571.44 KB)
- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Romanian
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- Slovak
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- Slovenian
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- Spanish
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- Swedish
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Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Irbesartan Teva : EPAR - All Authorised presentations (PDF/39.04 KB)

First published: 16/11/2009
Last updated: 30/05/2012
- Bulgarian
  (PDF/75.35 KB)
- Czech
  (PDF/48.62 KB)
- Danish
  (PDF/40.67 KB)
- Dutch
  (PDF/45.79 KB)
- Estonian
  (PDF/26.87 KB)
- Finnish
  (PDF/50.22 KB)
- French
  (PDF/46.63 KB)
- German
  (PDF/15.62 KB)
- Greek
  (PDF/51.79 KB)
- Hungarian
  (PDF/115.28 KB)
- Icelandic
  (PDF/39.76 KB)
- Italian
  (PDF/46.49 KB)
- Latvian
  (PDF/74.44 KB)
- Lithuanian
  (PDF/48.91 KB)
- Maltese
  (PDF/75.79 KB)
- Norwegian
  (PDF/47.92 KB)
- Polish
  (PDF/29.49 KB)
- Portuguese
  (PDF/49.04 KB)
- Romanian
  (PDF/69.32 KB)
- Slovak
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- Slovenian
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- Spanish
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- Swedish
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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.

Assessment history

Changes since initial authorisation of medicine

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Irbesartan Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/177.76 KB) (updated)

First published: 27/04/2010
Last updated: 05/09/2023
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Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Adopted

First published: 05/07/2021
- Bulgarian
  (PDF/145.18 KB)
- Croatian
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- Czech
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- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Polish
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- Portuguese
  (PDF/128.87 KB)
- Romanian
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- Slovak
  (PDF/135.07 KB)
- Slovenian
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- Spanish
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- Swedish
  (PDF/126.99 KB)
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Adopted

First published: 02/03/2021
EMA/47245/2021
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Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 12/06/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Italian
  (PDF/95.54 KB)
- Latvian
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- Lithuanian
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- Maltese
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- Polish
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- Portuguese
  (PDF/96.47 KB)
- Romanian
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- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019
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Irbesartan Teva-H-C-1093-A31-17 : 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 (PDF/48.81 KB)

First published: 01/10/2014
Last updated: 01/10/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Italian
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- Latvian
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- Lithuanian
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- Maltese
  (PDF/84.23 KB)
- Polish
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- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
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- Slovenian
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- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
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Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
EMA/PRAC/294920/2014

Irbesartan Teva

Table of contents

Overview

Irbesartan Teva : EPAR - Summary for the public (PDF/43.36 KB)

Authorisation details

Product information

Irbesartan Teva : EPAR - Product Information (PDF/497.85 KB) (updated)

Irbesartan Teva : EPAR - All Authorised presentations (PDF/39.04 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Irbesartan Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/177.76 KB) (updated)

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions (PDF/99.42 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Irbesartan Teva-H-C-1093-A31-17 : 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 (PDF/48.81 KB)

Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Initial marketing-authorisation documents

Irbesartan Teva : EPAR - Public assessment report (PDF/350.66 KB)

CHMP summary of positive opinion for Irbesartan Teva (PDF/32.94 KB)

News

More information on Irbesartan Teva

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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