Aprovel

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) for Aprovel. 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 Aprovel.

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

: Aprovel is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Aprovel is also used to treat kidney disease in adults with hypertension and type-2 diabetes. The medicine can only be obtained with a prescription.

: The usual recommended dose of Aprovel 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, Aprovel 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.

: The active substance in Aprovel, 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.

: Aprovel was originally studied in 11 trials for its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use in combination with hydrochlorothiazide was also examined in 1,736 patients. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type-2 diabetes. Aprovel was used for two years or more. One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine. The second study looked at whether Aprovel increased the time taken until the patients’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died. In this study, Aprovel was compared with placebo and with amlodipine.

: In the blood pressure studies, Aprovel was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. When used with hydrochlorothiazide, the effects of the two medicines were additive.
In the first kidney-disease study, Aprovel was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. In the second kidney-disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo. There was a 23% relative risk reduction compared with amlodipine. The main benefit was on the effect on blood creatinine levels.

: The most common side effect with Aprovel (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels). For the full list of all side effects reported with Aprovel, see the package leaflet.
Aprovel must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Aprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.

: The CHMP decided that Aprovel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

: The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel on 27 August 1997.
For more information about treatment with Aprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Aprovel : EPAR - Summary for the public (PDF/74.21 KB)

First published: 05/05/2009
Last updated: 23/09/2013
- Bulgarian
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- Czech
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- Danish
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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
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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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This EPAR was last updated on 06/07/2023

Authorisation details

Product details
Name	Aprovel
Agency product number	EMEA/H/C/000141
Active substance	irbesartan
International non-proprietary name (INN) or common name	irbesartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09CA04

Publication details
Marketing-authorisation holder	Sanofi Winthrop Industrie
Revision	48
Date of issue of marketing authorisation valid throughout the European Union	26/08/1997
Contact address	82 Avenue Raspail 94250 Gentilly FRANCE

Product information

06/07/2023 Aprovel - EMEA/H/C/000141 - N/0194

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Aprovel : EPAR - Product Information (PDF/1.04 MB)

First published: 22/04/2009
Last updated: 06/07/2023
- Bulgarian
  (PDF/1.35 MB)
- Croatian
  (PDF/1.15 MB)
- Czech
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- Danish
  (PDF/1.21 MB)
- Dutch
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- Estonian
  (PDF/1.12 MB)
- Finnish
  (PDF/1.09 MB)
- French
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- German
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- Greek
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- Hungarian
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- Icelandic
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- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
  (PDF/1.31 MB)
- Polish
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- Portuguese
  (PDF/1.37 MB)
- Romanian
  (PDF/1.27 MB)
- Slovak
  (PDF/1.29 MB)
- Slovenian
  (PDF/1.15 MB)
- Spanish
  (PDF/1.36 MB)
- Swedish
  (PDF/1.13 MB)

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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Aprovel : EPAR - All Authorised presentations (PDF/19.97 KB)

First published: 17/04/2007
Last updated: 17/04/2007
- Bulgarian
  (PDF/106.66 KB)
- Czech
  (PDF/19.41 KB)
- Danish
  (PDF/22.05 KB)
- Dutch
  (PDF/22.32 KB)
- Estonian
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- Finnish
  (PDF/22.88 KB)
- French
  (PDF/23.32 KB)
- German
  (PDF/22.47 KB)
- Greek
  (PDF/107.06 KB)
- Hungarian
  (PDF/61.39 KB)
- Italian
  (PDF/22.66 KB)
- Latvian
  (PDF/22.68 KB)
- Lithuanian
  (PDF/107.41 KB)
- Polish
  (PDF/62.85 KB)
- Portuguese
  (PDF/23.29 KB)
- Romanian
  (PDF/103.07 KB)
- Slovak
  (PDF/23.3 KB)
- Slovenian
  (PDF/60 KB)
- Spanish
  (PDF/23.05 KB)
- Swedish
  (PDF/23 KB)

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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Aprovel : EPAR - Procedural steps taken and scientific information after authorisation (PDF/3.41 MB)

First published: 05/05/2009
Last updated: 06/07/2023
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Aprovel : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

First published: 22/05/2019
- 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)
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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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Aprovel-H-C-PSUSA-00001782/201508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/68.1 KB)

First published: 15/07/2016
Last updated: 15/07/2016
EMA/367566/2016
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Aprovel-H-C-141-A31-0154 : 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 recommenda... (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
  (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)
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Aprovel-H-C-141-A31-0154 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
EMA/PRAC/294920/2014
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Aprovel-H-C-141-II-0148 : EPAR - Assessment Report - Variation (PDF/238.14 KB)

Adopted

First published: 23/09/2013
Last updated: 23/09/2013
EMA/CHMP/220046/2013
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CHMP post-authorisation summary of positive opinion for Aprovel (PDF/60.97 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388259/2013
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Aprovel-H-C-141-P45-0019 : EPAR - Assessment Report (PDF/257.44 KB)

Adopted

First published: 13/05/2013
Last updated: 13/05/2013
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Aprovel : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/115.61 KB)

First published: 16/10/2006
Last updated: 16/10/2006
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Aprovel-H-C-141-II-0075 : EPAR - Scientific Discussion - Variation (PDF/387.44 KB)

Adopted

First published: 16/10/2006
Last updated: 16/10/2006

Aprovel

Table of contents

Overview

Aprovel : EPAR - Summary for the public (PDF/74.21 KB)

Authorisation details

Product information

Aprovel : EPAR - Product Information (PDF/1.04 MB)

Aprovel : EPAR - All Authorised presentations (PDF/19.97 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Aprovel : EPAR - Procedural steps taken and scientific information after authorisation (PDF/3.41 MB)

Aprovel : EPAR - Scientific conclusions - Annex IV (PDF/99.42 KB)

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

Aprovel-H-C-PSUSA-00001782/201508 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/68.1 KB)

Aprovel-H-C-141-A31-0154 : 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 recommenda... (PDF/48.81 KB)

Aprovel-H-C-141-A31-0154 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Aprovel-H-C-141-II-0148 : EPAR - Assessment Report - Variation (PDF/238.14 KB)

CHMP post-authorisation summary of positive opinion for Aprovel (PDF/60.97 KB)

Aprovel-H-C-141-P45-0019 : EPAR - Assessment Report (PDF/257.44 KB)

Aprovel : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/115.61 KB)

Aprovel-H-C-141-II-0075 : EPAR - Scientific Discussion - Variation (PDF/387.44 KB)

Initial marketing-authorisation documents

Aprovel : EPAR - Procedural steps taken before authorisation (PDF/95.95 KB)

Aprovel : EPAR - Scientific Discussion (PDF/492.74 KB)

News

More information on Aprovel

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

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