CoAprovel

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) for CoAprovel. 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 CoAprovel.

: CoAprovel 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; 300 mg irbesartan and 25 mg hydrochlorothiazide).

: CoAprovel 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.

: The dose of CoAprovel 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. CoAprovel may be added to some other treatments for hypertension.

: CoAprovel 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.

: Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel. It can be used with hydrochlorothiazide to treat hypertension. The studies of Karvea / Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel. Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

: CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure. Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.

: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle). For the full list of all side effects reported with CoAprovel, see the package leaflet.
CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, 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. CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
CoAprovel 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. Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels. The full list of these medicines is given in the package leaflet.

: The CHMP decided that CoAprovel’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 EU for CoAprovel on 15 October 1998.
For more information about treatment with CoAprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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CoAprovel : EPAR - Summary for the public (PDF/74.91 KB)

First published: 04/05/2009
Last updated: 23/09/2013
- Bulgarian
  (PDF/105.13 KB)
- Croatian
  (PDF/88.27 KB)
- Czech
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- Danish
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- Dutch
  (PDF/76.75 KB)
- Estonian
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- Finnish
  (PDF/96.65 KB)
- French
  (PDF/77.95 KB)
- German
  (PDF/99.95 KB)
- Greek
  (PDF/103.68 KB)
- Hungarian
  (PDF/95.47 KB)
- Italian
  (PDF/75.01 KB)
- Latvian
  (PDF/98.37 KB)
- Lithuanian
  (PDF/120.98 KB)
- Maltese
  (PDF/102.88 KB)
- Polish
  (PDF/125.63 KB)
- Portuguese
  (PDF/97.38 KB)
- Romanian
  (PDF/119.36 KB)
- Slovak
  (PDF/121.62 KB)
- Slovenian
  (PDF/115.35 KB)
- Spanish
  (PDF/97.12 KB)
- Swedish
  (PDF/98.86 KB)

This EPAR was last updated on 16/05/2023

Authorisation details

Product details
Name	CoAprovel
Agency product number	EMEA/H/C/000222
Active substance	irbesartan hydrochlorothiazide
International non-proprietary name (INN) or common name	irbesartan hydrochlorothiazide
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DA04

Publication details
Marketing-authorisation holder	Sanofi Winthrop Industrie
Revision	47
Date of issue of marketing authorisation valid throughout the European Union	14/10/1998
Contact address	82 Avenue Raspail 94250 Gentilly FRANCE

Product information

12/05/2023 CoAprovel - EMEA/H/C/000222 - WS2452

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CoAprovel : EPAR - Product Information (PDF/1.12 MB) (updated)

First published: 19/10/2009
Last updated: 16/05/2023
- Bulgarian
  (PDF/1.39 MB)
- Croatian
  (PDF/1.22 MB)
- Czech
  (PDF/1.32 MB)
- Danish
  (PDF/1.07 MB)
- Dutch
  (PDF/954.6 KB)
- Estonian
  (PDF/929.33 KB)
- Finnish
  (PDF/946.34 KB)
- French
  (PDF/1.05 MB)
- German
  (PDF/1.11 MB)
- Greek
  (PDF/1.63 MB)
- Hungarian
  (PDF/1.16 MB)
- Icelandic
  (PDF/892.98 KB)
- Italian
  (PDF/972.42 KB)
- Latvian
  (PDF/1.11 MB)
- Lithuanian
  (PDF/1.22 MB)
- Maltese
  (PDF/1.61 MB)
- Norwegian
  (PDF/1.04 MB)
- Polish
  (PDF/1.19 MB)
- Portuguese
  (PDF/872.34 KB)
- Romanian
  (PDF/1.35 MB)
- Slovak
  (PDF/1.09 MB)
- Slovenian
  (PDF/1.26 MB)
- Spanish
  (PDF/497.04 KB)
- Swedish
  (PDF/792.89 KB)

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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CoAprovel : EPAR - All Authorised presentations (PDF/15.78 KB)

First published: 17/04/2007
Last updated: 17/04/2007
- Bulgarian
  (PDF/82.97 KB)
- Czech
  (PDF/45.53 KB)
- Danish
  (PDF/15.75 KB)
- Dutch
  (PDF/14.82 KB)
- Estonian
  (PDF/16.63 KB)
- Finnish
  (PDF/16.03 KB)
- French
  (PDF/15.84 KB)
- German
  (PDF/15.11 KB)
- Greek
  (PDF/83.14 KB)
- Hungarian
  (PDF/45.26 KB)
- Italian
  (PDF/15.15 KB)
- Latvian
  (PDF/84.2 KB)
- Lithuanian
  (PDF/82.41 KB)
- Polish
  (PDF/47.12 KB)
- Portuguese
  (PDF/15.98 KB)
- Slovak
  (PDF/81.73 KB)
- Slovenian
  (PDF/43.9 KB)
- Spanish
  (PDF/15.69 KB)
- Swedish
  (PDF/15.54 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

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CoAprovel : EPAR - Procedural steps taken and scientific information after authorisation (PDF/443.38 KB) (updated)

First published: 26/10/2009
Last updated: 16/05/2023
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CoAprovel : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 22/05/2019
- Croatian
  (PDF/125.02 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

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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CoAprove-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/75.5 KB)

First published: 10/11/2017
Last updated: 10/11/2017
EMA/715525/2017
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CoAprovel-H-C-222-A31-0162 : 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 recommen... (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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CoAprovel-H-C-222-A31-0162 : 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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CoAprovel-H-C-222-II-0155 : EPAR - Assessment Report - Variation (PDF/237.86 KB)

Adopted

First published: 23/09/2013
Last updated: 23/09/2013
EMA/CHMP/377913/2013
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CHMP post-authorisation summary of positive opinion for CoAprovel (PDF/66.26 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388266/2013
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CoAprovel : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/115.14 KB)

First published: 17/10/2006
Last updated: 17/10/2006

CoAprovel

Table of contents

Overview

CoAprovel : EPAR - Summary for the public (PDF/74.91 KB)

Authorisation details

Product information

CoAprovel : EPAR - Product Information (PDF/1.12 MB) (updated)

CoAprovel : EPAR - All Authorised presentations (PDF/15.78 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

CoAprovel : EPAR - Procedural steps taken and scientific information after authorisation (PDF/443.38 KB) (updated)

CoAprovel : EPAR - Scientific conclusions (PDF/99.42 KB)

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

CoAprove-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/75.5 KB)

CoAprovel-H-C-222-A31-0162 : 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 recommen... (PDF/48.81 KB)

CoAprovel-H-C-222-A31-0162 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

CoAprovel-H-C-222-II-0155 : EPAR - Assessment Report - Variation (PDF/237.86 KB)

CHMP post-authorisation summary of positive opinion for CoAprovel (PDF/66.26 KB)

CoAprovel : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/115.14 KB)

Initial marketing-authorisation documents

CoAprovel : EPAR - Scientific Discussion (PDF/569.32 KB)

CoAprovel : EPAR - Procedural steps taken before authorisation (PDF/93.65 KB)

News

More information on CoAprovel

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

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