Irbesartan/Hydrochlorothiazide Teva

irbesartan / hydrochlorothiazide

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/Hydrochlorothiazide Teva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide. It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; and 300 mg irbesartan and 25 mg hydrochlorothiazide).
Irbesartan/Hydrochlorothiazide Teva is a ‘generic medicine’. This means that Irbesartan/Hydrochlorothiazide Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CoAprovel.

: Irbesartan/Hydrochlorothiazide Teva 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.

: Irbesartan/Hydrochlorothiazide Teva is taken by mouth. The dose of Irbesartan/Hydrochlorothiazide Teva 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. Irbesartan/Hydrochlorothiazide Teva may be added to other treatments for hypertension.

: Irbesartan/Hydrochlorothiazide Teva 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.

: Because Irbesartan/Hydrochlorothiazide Teva 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.

: Because Irbesartan/Hydrochlorothiazide Teva 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.

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

: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan/Hydrochlorothiazide Teva on 26 November 2009.
For more information about treatment with Irbesartan/Hydrochlorothiazide Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

List item

Irbesartan / Hydrochlorothiazide Teva : EPAR - Summary for the public (PDF/91.61 KB)

First published: 16/12/2009
Last updated: 10/11/2015
- Bulgarian
  (PDF/124.49 KB)
- Croatian
  (PDF/103.36 KB)
- Czech
  (PDF/118.28 KB)
- Danish
  (PDF/98.04 KB)
- Dutch
  (PDF/98.55 KB)
- Estonian
  (PDF/96.49 KB)
- Finnish
  (PDF/98.51 KB)
- French
  (PDF/99.29 KB)
- German
  (PDF/99.58 KB)
- Greek
  (PDF/125.42 KB)
- Hungarian
  (PDF/113.38 KB)
- Italian
  (PDF/98.2 KB)
- Latvian
  (PDF/113.99 KB)
- Lithuanian
  (PDF/114.7 KB)
- Maltese
  (PDF/117.69 KB)
- Polish
  (PDF/118.17 KB)
- Portuguese
  (PDF/98.38 KB)
- Romanian
  (PDF/115.09 KB)
- Slovak
  (PDF/115.69 KB)
- Slovenian
  (PDF/105.79 KB)
- Spanish
  (PDF/97.33 KB)
- Swedish
  (PDF/96 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 12/06/2019

Authorisation details

Product details
Name	Irbesartan/Hydrochlorothiazide Teva
Agency product number	EMEA/H/C/001112
Active substance	irbesartan hydrochlorothiazide
International non-proprietary name (INN) or common name	irbesartan / hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DA04
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	26/11/2009
Contact address	Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

Product information

11/04/2019 Irbesartan/Hydrochlorothiazide Teva - EMEA/H/C/001112 - A31/0041

List item

Irbesartan / Hydrochlorothiazide Teva : EPAR - Product Information (PDF/542.67 KB) (updated)

First published: 16/12/2009
Last updated: 12/06/2019
- Bulgarian
  (PDF/734.13 KB)
- Croatian
  (PDF/613.34 KB)
- Czech
  (PDF/569.71 KB)
- Danish
  (PDF/618.78 KB)
- Dutch
  (PDF/556.25 KB)
- Estonian
  (PDF/572.63 KB)
- Finnish
  (PDF/589.97 KB)
- French
  (PDF/588.54 KB)
- German
  (PDF/581.61 KB)
- Greek
  (PDF/660 KB)
- Hungarian
  (PDF/624.02 KB)
- Icelandic
  (PDF/628.72 KB)
- Italian
  (PDF/530.58 KB)
- Latvian
  (PDF/612.65 KB)
- Lithuanian
  (PDF/692.27 KB)
- Maltese
  (PDF/712.46 KB)
- Norwegian
  (PDF/593.11 KB)
- Polish
  (PDF/720.54 KB)
- Portuguese
  (PDF/548.77 KB)
- Romanian
  (PDF/634.4 KB)
- Slovak
  (PDF/687.24 KB)
- Slovenian
  (PDF/677.59 KB)
- Spanish
  (PDF/573.21 KB)
- Swedish
  (PDF/535.42 KB)

Annex I - Summary of product characteristics
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

List item

Irbesartan / Hydrochlorothiazide Teva : EPAR - All Authorised presentations (PDF/66.13 KB)

First published: 16/12/2009
Last updated: 21/05/2013
- Bulgarian
  (PDF/82.62 KB)
- Czech
  (PDF/42.64 KB)
- Danish
  (PDF/71.63 KB)
- Dutch
  (PDF/66 KB)
- Estonian
  (PDF/29.86 KB)
- Finnish
  (PDF/71.12 KB)
- French
  (PDF/21.51 KB)
- German
  (PDF/14.36 KB)
- Greek
  (PDF/100.98 KB)
- Hungarian
  (PDF/98.91 KB)
- Icelandic
  (PDF/68.33 KB)
- Italian
  (PDF/50.3 KB)
- Latvian
  (PDF/97.73 KB)
- Lithuanian
  (PDF/64.67 KB)
- Maltese
  (PDF/75.25 KB)
- Norwegian
  (PDF/18.4 KB)
- Polish
  (PDF/101.7 KB)
- Portuguese
  (PDF/38.4 KB)
- Romanian
  (PDF/51.09 KB)
- Slovak
  (PDF/61.41 KB)
- Slovenian
  (PDF/67.52 KB)
- Spanish
  (PDF/45.8 KB)
- Swedish
  (PDF/24.14 KB)

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.

Assessment history

Changes since initial authorisation of medicine

List item

Irbesartan / Hydrochlorothiazide Teva : EPAR - Procedural steps taken and scientific information after authorisation (PDF/149.24 KB) (updated)

First published: 30/03/2010
Last updated: 12/06/2019
List item

Irbesartan / Hydrochlorothiazide Teva : EPAR - Scientific conclusions - Annex IV (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
  (PDF/96.12 KB)
- Dutch
  (PDF/99.3 KB)
- Estonian
  (PDF/94.4 KB)
- Finnish
  (PDF/97.12 KB)
- French
  (PDF/97.56 KB)
- German
  (PDF/100.2 KB)
- Greek
  (PDF/142.79 KB)
- Hungarian
  (PDF/119.82 KB)
- Italian
  (PDF/95.54 KB)
- Latvian
  (PDF/130.68 KB)
- Lithuanian
  (PDF/130.84 KB)
- Maltese
  (PDF/133.78 KB)
- Polish
  (PDF/130.65 KB)
- Portuguese
  (PDF/96.47 KB)
- Romanian
  (PDF/128.25 KB)
- Slovak
  (PDF/119.14 KB)
- Slovenian
  (PDF/124.14 KB)
- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
List item

Sartans Article 31 referral - CHMP assessment report (PDF/531.32 KB)

Adopted

First published: 02/05/2019
EMA/217823/2019
List item

Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differe... (PDF/42.12 KB)

First published: 02/10/2014
Last updated: 02/10/2014
- Bulgarian
  (PDF/87.49 KB)
- Croatian
  (PDF/80.12 KB)
- Czech
  (PDF/82.81 KB)
- Danish
  (PDF/49.01 KB)
- Dutch
  (PDF/49.82 KB)
- Estonian
  (PDF/50.6 KB)
- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
  (PDF/53.54 KB)
- Greek
  (PDF/89.54 KB)
- Hungarian
  (PDF/68.7 KB)
- Italian
  (PDF/51.13 KB)
- Latvian
  (PDF/81.63 KB)
- Lithuanian
  (PDF/82.54 KB)
- Maltese
  (PDF/84.23 KB)
- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
  (PDF/81.5 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
List item

Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 02/10/2014
Last updated: 02/10/2014
EMA/PRAC/294920/2014

Irbesartan/Hydrochlorothiazide Teva

Table of contents

Overview