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Sabervel (irbesartan) - C09CA04

Updated on site: 10-Oct-2017

Medication nameSabervel
ATC CodeC09CA04
Substanceirbesartan
ManufacturerPharmathen S.A.

What is Sabervel?

EMEA/H/C/002510

Sabervel

irbesartan

This is a summary of the European public assessment report (EPAR) for S bervel. It explains how the

favour of granting a marketing authorisation and its recommendations on the conditions of use for Sabervel.

Sabervel is a ‘generic medicine’. This means that Sabervel is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aprovel. For more information on generic medicines, see the question-and-answer document here.

WhatMedicinalis Sabervel used for?

Sabervel is used in dults who have essential hypertension (high blood pressure). ‘Essential’ means that the hyperte s on has no obvious cause. Sabervel is also used to treat kidney disease in adults with hypertens on and type 2 diabetes.

The me icine can only be obtained with a prescription.

How is Sabervel used?

The usual recommended dose of Sabervel 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.

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

marketing authorisation.

In patients with hypertension and type 2 diabetes, Sabervel is added to 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 Sabervel work?

The active substance in Sabervel, 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 Sabervel been studied?

Because Sabervel is a generic medicine, studies in patients have been limited o ests to determine that it is bioequivalent to the reference medicine, Aprovel. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Sabervel is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medici e’s.

The CHMP concluded that, in accordance with EU requirements, Sabervel has been shown to have

Aprovel, the benefit outweighs the identified risk. The Committee recommended that Sabervel be given

Other information about Sabervel

The European Commission granted a marketing authorisation valid throughout the European Union for

TheMedicinalfull EPAR for S bervel can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about

treatment w th Sabervel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency’s website. This summary was last updated in 03-2012.

Sabervel

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