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). 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).
Active Substances (1)
irbesartan
Documents (14)
Irbesartan Teva : EPAR - Procedural steps taken and scientific information after authorisation
April 26, 2010
CHANGES_SINCE_INITIAL_AUTHORISATION
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
September 30, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report - Article 31
September 30, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Irbesartan Teva : EPAR - Public assessment report
November 15, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Irbesartan Teva : EPAR - Product Information
November 15, 2009
DRUG_PRODUCT_INFORMATION
CHMP summary of positive opinion for Irbesartan Teva
July 22, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Irbesartan Teva : EPAR - Summary for the public
November 15, 2009
OVERVIEW_DOCUMENT
Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions
June 12, 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
Irbesartan Teva : EPAR - All Authorised presentations
November 15, 2009
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) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines
July 5, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Irbesartan Teva : EPAR - Public assessment report
November 15, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Irbesartan Teva
July 22, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (8)
Question
How is Irbesartan Teva used?
Answer
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.
Question
How does Irbesartan Teva work?
Answer
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.
Question
Other information about Irbesartan Teva
Answer
The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009.
Question
What are the benefit and risk of Irbesartan Teva?
Answer
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.
Question
Why has Irbesartan Teva been approved?
Answer
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.
Question
What is Irbesartan Teva?
Answer
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.
Question
What is Irbesartan Teva used for?
Answer
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.
Question
How has Irbesartan Teva been studied?
Answer
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.