Exforge

amlodipine / valsartan

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 Exforge. 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 Exforge.

: Exforge is a medicine that contains two active substances, amlodipine and valsartan. It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).

: Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘Essential’ means that the hypertension has no obvious cause.
The medicine can only be obtained with a prescription.

: Exforge is taken by mouth as one tablet once a day with some water. The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet.

: Exforge contains two active substances, amlodipine and valsartan. Both are anti–hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax.
Valsartan 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, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

: Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.

: The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

: The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Exforge, see the package leaflet.
Exforge must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives’ class, to valsartan, or to 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. Exforge must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure). Exforge must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment. For the full list of restrictions, see the package leaflet.

: The CHMP decided that Exforge’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 Exforge on 17 January 2007.
For more information about treatment with Exforge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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Exforge : EPAR - Summary for the public (PDF/75.24 KB)

First published: 05/05/2009
Last updated: 05/08/2015
- Bulgarian
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- Slovak
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- Slovenian
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- Swedish
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This EPAR was last updated on 11/11/2022

Authorisation details

Product details
Name	Exforge
Agency product number	EMEA/H/C/000716
Active substance	valsartan amlodipine (as amlodipine besilate)
International non-proprietary name (INN) or common name	amlodipine valsartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DB01

Publication details
Marketing-authorisation holder	Novartis Europharm Limited
Revision	31
Date of issue of marketing authorisation valid throughout the European Union	16/01/2007
Contact address	Vista Building Elm Park Merrion Road Dublin 4 Ireland

Product information

10/11/2022 Exforge - EMEA/H/C/000716 - WS2337/G

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Exforge : EPAR - Product information (PDF/374.85 KB)

First published: 05/05/2009
Last updated: 11/11/2022
- Bulgarian
  (PDF/492.04 KB)
- Croatian
  (PDF/457.9 KB)
- Czech
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- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Icelandic
  (PDF/377.68 KB)
- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Romanian
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- Slovak
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- Slovenian
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- Spanish
  (PDF/392.35 KB)
- Swedish
  (PDF/433.43 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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Exforge : EPAR - All Authorised presentations (PDF/142.51 KB)

First published: 20/05/2008
Last updated: 05/08/2010
- Bulgarian
  (PDF/87.19 KB)
- Croatian
  (PDF/50.22 KB)
- Czech
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- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Icelandic
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- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
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- Romanian
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- Slovak
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- Slovenian
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- Spanish
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- Swedish
  (PDF/19.78 KB)

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Assessment history

Changes since initial authorisation of medicine

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Exforge : EPAR - Procedural steps taken and scientific information after authorisation (PDF/388.97 KB)

First published: 05/05/2009
Last updated: 11/11/2022
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Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Adopted

First published: 05/07/2021
- Bulgarian
  (PDF/145.18 KB)
- Croatian
  (PDF/142.87 KB)
- Czech
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- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
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- Italian
  (PDF/126.56 KB)
- Latvian
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- Lithuanian
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- Maltese
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- Polish
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- Portuguese
  (PDF/128.87 KB)
- Romanian
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- Slovak
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- Slovenian
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- Spanish
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- Swedish
  (PDF/126.99 KB)
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Adopted

First published: 02/03/2021
EMA/47245/2021
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Exforge-H-C-716-A31-0098 : EPAR - Scientific conclusions (PDF/99.42 KB)

First published: 24/05/2019
- Bulgarian
  (PDF/136.15 KB)
- Croatian
  (PDF/125.02 KB)
- Czech
  (PDF/131.08 KB)
- Danish
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- Dutch
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- Estonian
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- Finnish
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- French
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- German
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- Greek
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- Hungarian
  (PDF/119.82 KB)
- Italian
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- Latvian
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- Lithuanian
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- Maltese
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- Polish
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- Portuguese
  (PDF/96.47 KB)
- Romanian
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- Slovak
  (PDF/119.14 KB)
- Slovenian
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- Spanish
  (PDF/98.31 KB)
- Swedish
  (PDF/96.85 KB)
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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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Exforge-H-C-716-A31-0067 : 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 recommenda... (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
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- Finnish
  (PDF/49.15 KB)
- French
  (PDF/51.91 KB)
- German
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- Greek
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- Hungarian
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- Italian
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- Latvian
  (PDF/81.63 KB)
- Lithuanian
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- Maltese
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- Polish
  (PDF/83.62 KB)
- Portuguese
  (PDF/49.74 KB)
- Romanian
  (PDF/88.19 KB)
- Slovak
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- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/50.51 KB)
- Swedish
  (PDF/50.18 KB)
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Exforge-H-C-716-A31-0067 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Adopted

First published: 01/10/2014
Last updated: 01/10/2014
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Exforge-H-C-716-WS-0360 : EPAR - Assessment Report - Variation (PDF/329.42 KB)

Adopted

First published: 11/12/2013
Last updated: 11/12/2013
EMA/CHMP/356249/2013
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CHMP post-authorisation summary of positive opinion for Exforge (PDF/68.5 KB)

Adopted

First published: 28/06/2013
Last updated: 28/06/2013
EMA/CHMP/388283/2013
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Exforge-H-C-716-WS-0100-G : EPAR - Assessment Report - Variation (PDF/636.9 KB)

Adopted

First published: 07/09/2011
Last updated: 07/09/2011

Exforge

Table of contents

Overview

Exforge : EPAR - Summary for the public (PDF/75.24 KB)

Authorisation details

Product information

Exforge : EPAR - Product information (PDF/374.85 KB)

Exforge : EPAR - All Authorised presentations (PDF/142.51 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Exforge : EPAR - Procedural steps taken and scientific information after authorisation (PDF/388.97 KB)

Angiotensin-II-receptor antagonists (sartans) : Scientific conclusions - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/119.28 KB)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines (PDF/362.31 KB)

Exforge-H-C-716-A31-0098 : EPAR - Scientific conclusions (PDF/99.42 KB)

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

Exforge-H-C-716-A31-0067 : 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 recommenda... (PDF/48.81 KB)

Exforge-H-C-716-A31-0067 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Exforge-H-C-716-WS-0360 : EPAR - Assessment Report - Variation (PDF/329.42 KB)

CHMP post-authorisation summary of positive opinion for Exforge (PDF/68.5 KB)

Exforge-H-C-716-WS-0100-G : EPAR - Assessment Report - Variation (PDF/636.9 KB)

Initial marketing-authorisation documents

Exforge : EPAR - Procedural steps taken before authorisation (PDF/23.32 KB)

Exforge : EPAR - Scientific Discussion (PDF/333.19 KB)

News

More information on Exforge

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

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