Edarbi

azilsartan medoxomil

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 Edarbi. 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 Edarbi.

: Edarbi is a medicine that contains the active substance azilsartan medoxomil. It is available as tablets (20, 40 and 80 mg).

: Edarbi is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: Edarbi is taken by mouth and the usual recommended dose is 40 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 80 mg, or another medicine for hypertension, such as chlortalidone or hydrochlorothiazide, can be added.

: The active substance in Edarbi, azilsartan medoxomil, 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, azilsartan medoxomil stops the hormone from having an effect, therefore allowing the blood vessels to widen. This allows the blood pressure to fall towards normal, thus reducing the risks associated with high blood pressure, such as having a stroke.

: Eight main studies involving over 6,000 patients with essential hypertension were carried out with Edarbi.
Five studies investigated the effects of Edarbi taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil). The patients in these studies had mild to moderate hypertension.
Three studies investigated the effects of Edarbi in combination with other antihypertensive medicines (chlortalidone, amlodipine, and hydrochlorothiazide). The patients in the combination studies had moderate to severe hypertension.
The studies lasted between six and 56 weeks and the main measure of effectiveness was the change in the systolic blood pressure (blood pressure when the heart is contracting).

: Edarbi on its own was more effective than placebo. In the two studies with Edarbi taken alone compared with placebo, patients had an average fall in systolic blood pressure of about 13.5 mmHg on Edarbi 40 mg and a fall of about 14.5 mmHg on Edarbi 80 mg after 6 weeks. This compares with a fall of 0.3 to 1.4 mmHg in the patients taking placebo.
When Edarbi alone was compared with other medicines, 80 mg of Edarbi was more effective in lowering blood pressure than the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg). Edarbi 40 and 80 mg was also more effective than ramipril (10 mg).
The studies also showed that Edarbi, when taken in combination with other medicines, can produce additional decreases in blood pressure compared with when these medicines are taken without Edarbi.

: Side effects with Edarbi are generally mild or moderate, with the most common side effect being dizziness. For the full list of all side effects reported with Edarbi, see the package leaflet.
Edarbi must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is also not recommended. Edarbi must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

: The CHMP concluded that Edarbi belongs to an established class of medicines in the treatment of hypertension and its risks are similar to others within this class. The Committee decided that the benefits of Edarbi are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorisation.

: A risk management plan has been developed to ensure that Edarbi is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Edarbi, including the appropriate precautions to be followed by healthcare professionals and patients.

: The European Commission granted a marketing authorisation valid throughout the European Union for Edarbi on 7 December 2011.
For more information about treatment with Edarbi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Edarbi : EPAR - Summary for the public (PDF/77.72 KB)

First published: 15/12/2011
Last updated: 13/07/2015
EMA/807101/2011
- Bulgarian
  (PDF/103.92 KB)
- Croatian
  (PDF/97.53 KB)
- Czech
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- Danish
  (PDF/76.96 KB)
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- Estonian
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- Finnish
  (PDF/98.37 KB)
- French
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- German
  (PDF/100.49 KB)
- Greek
  (PDF/127.83 KB)
- Hungarian
  (PDF/98.93 KB)
- Italian
  (PDF/98.78 KB)
- Latvian
  (PDF/122.49 KB)
- Lithuanian
  (PDF/123.28 KB)
- Maltese
  (PDF/104.52 KB)
- Polish
  (PDF/103.05 KB)
- Portuguese
  (PDF/100.67 KB)
- Romanian
  (PDF/121.41 KB)
- Slovak
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- Slovenian
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- Spanish
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- Swedish
  (PDF/76.21 KB)
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Edarbi : EPAR - Risk-management-plan summary (PDF/48.93 KB)

First published: 18/03/2020

This EPAR was last updated on 17/03/2022

Authorisation details

Product details
Name	Edarbi
Agency product number	EMEA/H/C/002293
Active substance	Azilsartan medoxomil
International non-proprietary name (INN) or common name	azilsartan medoxomil
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09CA09

Publication details
Marketing-authorisation holder	Takeda Pharma A/S
Revision	10
Date of issue of marketing authorisation valid throughout the European Union	07/12/2011
Contact address	Delta Park 45 2665 Vallensbaek Strand Denmark

Product information

24/02/2022 Edarbi - EMEA/H/C/002293 - II/0030/G

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Edarbi : EPAR - Product Information (PDF/284.01 KB)

First published: 15/12/2011
Last updated: 17/03/2023
- Bulgarian
  (PDF/540.12 KB)
- Croatian
  (PDF/500.32 KB)
- Czech
  (PDF/520.23 KB)
- Danish
  (PDF/497.38 KB)
- Dutch
  (PDF/331.64 KB)
- Estonian
  (PDF/429.61 KB)
- Finnish
  (PDF/307.17 KB)
- French
  (PDF/481.52 KB)
- German
  (PDF/321.1 KB)
- Greek
  (PDF/540.94 KB)
- Hungarian
  (PDF/539.16 KB)
- Icelandic
  (PDF/282.29 KB)
- Italian
  (PDF/294.89 KB)
- Latvian
  (PDF/479.31 KB)
- Lithuanian
  (PDF/499.13 KB)
- Maltese
  (PDF/512.97 KB)
- Norwegian
  (PDF/345.94 KB)
- Polish
  (PDF/507 KB)
- Portuguese
  (PDF/446.36 KB)
- Romanian
  (PDF/544.01 KB)
- Slovak
  (PDF/491.34 KB)
- Slovenian
  (PDF/505.91 KB)
- Spanish
  (PDF/450.8 KB)
- Swedish
  (PDF/458.15 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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Edarbi : EPAR - All Authorised presentations (PDF/41.15 KB)

First published: 15/12/2011
Last updated: 18/05/2018
- Bulgarian
  (PDF/42.4 KB)
- Croatian
  (PDF/50.03 KB)
- Czech
  (PDF/33.2 KB)
- Danish
  (PDF/32.59 KB)
- Dutch
  (PDF/32.55 KB)
- Estonian
  (PDF/32.33 KB)
- Finnish
  (PDF/32.18 KB)
- French
  (PDF/39.13 KB)
- German
  (PDF/33.9 KB)
- Greek
  (PDF/36.97 KB)
- Hungarian
  (PDF/33.67 KB)
- Icelandic
  (PDF/32.73 KB)
- Italian
  (PDF/34 KB)
- Latvian
  (PDF/32.56 KB)
- Lithuanian
  (PDF/34.84 KB)
- Maltese
  (PDF/34.85 KB)
- Norwegian
  (PDF/32.76 KB)
- Polish
  (PDF/34.85 KB)
- Portuguese
  (PDF/32.54 KB)
- Romanian
  (PDF/32.85 KB)
- Slovak
  (PDF/33.65 KB)
- Slovenian
  (PDF/33.16 KB)
- Spanish
  (PDF/34.87 KB)
- Swedish
  (PDF/33.39 KB)

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Edarbi is indicated for the treatment of essential hypertension in adults.

Assessment history

Changes since initial authorisation of medicine

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Edarbi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/156.32 KB)

First published: 11/06/2012
Last updated: 17/03/2023
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Edarbi-H-C-2293-II-0030-G : EPAR - Assessment Report - Variation (PDF/531.74 KB)

Adopted

First published: 17/03/2023
EMA/202992/2022
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Edarbi-H-C-2293-A31-06 : 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 recommendati... (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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Edarbi-H-C-2293-A31-06 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
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Edarbi-H-C-2293-PSUV-08 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.07 KB)

First published: 02/07/2014
Last updated: 02/07/2014
EMA/CHMP/538715/2013

Edarbi

Table of contents

Overview

Edarbi : EPAR - Summary for the public (PDF/77.72 KB)

Edarbi : EPAR - Risk-management-plan summary (PDF/48.93 KB)

Authorisation details

Product information

Edarbi : EPAR - Product Information (PDF/284.01 KB)

Edarbi : EPAR - All Authorised presentations (PDF/41.15 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Edarbi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/156.32 KB)

Edarbi-H-C-2293-II-0030-G : EPAR - Assessment Report - Variation (PDF/531.74 KB)

Edarbi-H-C-2293-A31-06 : 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 recommendati... (PDF/48.81 KB)

Edarbi-H-C-2293-A31-06 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Edarbi-H-C-2293-PSUV-08 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/73.07 KB)

Initial marketing-authorisation documents

Edarbi : EPAR - Public assessment report (PDF/847.48 KB)

CHMP summary of positive opinion for Edarbi (PDF/51.88 KB)

News

More information on Edarbi

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