Karvea

irbesartan

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This is a summary of the European public assessment report (EPAR) for Karvea. 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 Karvea.

What is Karvea?

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

What is Karvea used for?

Karvea is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Karvea is also used to treat kidney disease in adults with hypertension and type-2 diabetes (non‑insulin-dependent diabetes).

The medicine can only be obtained with a prescription.

How is Karvea used?

The usual recommended dose of Karvea 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, Karvea 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.

How does Karvea work?

The active substance in Karvea, 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.

How has Karvea been studied?

Karvea was originally studied in 11 trials for its effects on blood pressure. Karvea 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, Karvea was studied in two large studies involving a total of 2,326 patients with type-2 diabetes. Karvea 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 Karvea 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, Karvea was compared with placebo and with amlodipine.

What benefit has Karvea shown during the studies?

In the blood pressure studies, Karvea 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, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. In the second kidney-disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, 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.

What is the risk associated with Karvea?

The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels). For the full list of all side effects reported with Karvea, see the package leaflet.

Karvea 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. Karvea 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.

Why has Karvea been approved?

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

Other information about Karvea

The European Commission granted a marketing authorisation valid throughout the European Union for Karvea on 27 August 1997.

For more information about treatment with Karvea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Karvea : EPAR - Summary for the public BG = bălgarski 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public ES = español 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public CS = čeština 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public DA = dansk 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public DE = Deutsch 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public ET = eesti keel 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public EL = elliniká 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public EN = English 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public FR = français 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public IT = italiano 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public LV = latviešu valoda 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public LT = lietuvių kalba 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public HU = magyar 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public MT = Malti 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public NL = Nederlands 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public PL = polski 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public PT = português 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public RO = română 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public SK = slovenčina 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public SL = slovenščina 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public FI = suomi 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public SV = svenska 06/05/2009 23/09/2013
Karvea : EPAR - Summary for the public HR = Hrvatski 06/05/2009 23/09/2013

This EPAR was last updated on 02/10/2014 .

Authorisation details

Product details

Product details for Karvea
NameKarvea
Agency product numberEMEA/H/C/000142
Active substance

irbesartan

International non-proprietary name (INN) or common name

irbesartan

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09CA04

Publication details

Publication details for Karvea
Marketing-authorisation holder

Sanofi-aventis groupe

Revision31
Date of issue of marketing authorisation valid throughout the European Union27/08/1997

Contact address:

Sanofi-aventis groupe
54 rue La Boétie
75008 Paris
France

Product information

Product information

04/09/2014  Karvea -EMEA/H/C/000142 -A31-0159

Name Language First published Last updated
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014
Karvea : EPAR - Product Information HR = Hrvatski 22/04/2009 02/10/2014

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
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  
Karvea : EPAR - All Authorised presentations HR = Hrvatski 17/04/2007  

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

Name Language First published Last updated
Karvea-H-C-142-A31-159 : EPAR - Assessment Report - Article 31 HR = Hrvatski 02/10/2014  
Karvea : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 06/05/2009 02/10/2014
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-A31-159 : 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 02/10/2014  
Karvea-H-C-142-II-153 : EPAR - Assessment Report - Variation HR = Hrvatski 23/09/2013  
CHMP post-authorisation summary of positive opinion for Karvea HR = Hrvatski 28/06/2013  
Karvea-H-C-142-P45-19 : EPAR - Assessment Report HR = Hrvatski 13/05/2013  
Karvea-H-C-142-II-80 : EPAR - Scientific Discussion - Variation HR = Hrvatski 11/07/2006  
Karvea : EPAR - Steps taken after authorisation when a cutoff date has been used HR = Hrvatski 11/07/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
Karvea : EPAR - Procedural steps taken before authorisation HR = Hrvatski 11/07/2006  
Karvea : EPAR - Scientific Discussion HR = Hrvatski 11/07/2006  

Authorised

This medicine is approved for use in the European Union

More information on Karvea