CoAprovel

irbesartan / hydrochlorothiazide

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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.

What is 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).

What is CoAprovel used for?

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.

How is CoAprovel used?

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.

How does CoAprovel work?

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.

How has CoAprovel been studied?

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).

What benefit has CoAprovel shown during the studies?

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.

What is the risk associated with CoAprovel?

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.

Why has CoAprovel been approved?

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

Other information about CoAprovel

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.

Name Language First published Last updated
CoAprovel : EPAR - Summary for the public BG = bălgarski 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public ES = español 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public CS = čeština 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public DA = dansk 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public DE = Deutsch 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public ET = eesti keel 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public EL = elliniká 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public EN = English 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public FR = français 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public IT = italiano 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public LV = latviešu valoda 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public LT = lietuvių kalba 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public HU = magyar 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public MT = Malti 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public NL = Nederlands 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public PL = polski 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public PT = português 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public RO = română 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public SK = slovenčina 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public SL = slovenščina 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public FI = suomi 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public SV = svenska 2009-05-04 2013-09-23
CoAprovel : EPAR - Summary for the public HR = Hrvatski 2009-05-04 2013-09-23

This EPAR was last updated on 10/11/2017 .

Authorisation details

Product details

Product details for CoAprovel
NameCoAprovel
Agency product numberEMEA/H/C/000222
Active substance

irbesartan / hydrochlorothiazide

International non-proprietary name (INN) or common name

irbesartan / hydrochlorothiazide

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DA04

Publication details

Publication details for CoAprovel
Marketing-authorisation holder

Sanofi Clir SNC

Revision33
Date of issue of marketing authorisation valid throughout the European Union15/10/1998

Contact address:

Sanofi Clir SNC
54, rue La Boétie
F-75008 Paris
France

Product information

Product information

22/08/2017  CoAprovel -EMEA/H/C/000222 -PSUSA/00001653/201609

Name Language First published Last updated
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10
CoAprovel : EPAR - Product Information HR = Hrvatski 2009-10-19 2017-11-10

Contents

  • 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.


Name Language First published Last updated
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  
CoAprovel : EPAR - All Authorised presentations HR = Hrvatski 2007-04-17  

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

Name Language First published Last updated
CoAprovel : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-10-25 2017-11-10
CoAprove-H-C-PSUSA-00001653-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation HR = Hrvatski 2017-11-10  
CoAprovel-H-C-222-A31-0162 : EPAR - Assessment Report - Article 31 HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
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 recommendation HR = Hrvatski 2014-10-01  
CoAprovel-H-C-222-II-0155 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-09-23  
CHMP post-authorisation summary of positive opinion for CoAprovel HR = Hrvatski 2013-06-28  
CoAprovel : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 2006-10-17  

Initial marketing-authorisation documents

Name Language First published Last updated
CoAprovel : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-10-17  
CoAprovel : EPAR - Scientific Discussion HR = Hrvatski 2006-10-17  

Authorised

This medicine is approved for use in the European Union

More information on CoAprovel