Overview

This is a summary of the European public assessment report (EPAR) for Amlodipine/Valsartan Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Amlodipine/Valsartan Mylan.

For practical information about using Amlodipine/Valsartan Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

Amlodipine/Valsartan Mylan is a medicine 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.

Amlodipine/Valsartan Mylan contains two active substances, amlodipine and valsartan. It is a ‘generic medicine’. This means that Amlodipine/Valsartan Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Exforge.

Amlodipine/Valsartan Mylan 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). One tablet is taken daily by mouth with water. It is recommended that the patient takes amlodipine and valsartan as separate tablets or capsules before switching to the combination tablet. The strength of the tablet to be used depends on the doses of amlodipine or valsartan that the patient was taking before.

The medicine can only be obtained with a prescription.

Amlodipine/Valsartan Mylan 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 through which calcium normally enters the cells. When calcium enters 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/Valsartan Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exforge. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

Because Amlodipine/Valsartan Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Amlodipine/Valsartan Mylan has been shown to have comparable quality and to be bioequivalent/be comparable to Exforge. Therefore, the CHMP’s view was that, as for Exforge, the benefit outweighs the identified risk. The Committee recommended that Amlodipine/Valsartan Mylan be approved for use in the EU.

A risk management plan has been developed to ensure that Amlodipine/Valsartan Mylan 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 Amlodipine/Valsartan Mylan, 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 Amlodipine/Valsartan Mylan on 22 March 2016.

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

Amlodipine / Valsartan Mylan : EPAR - Summary for the public

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Product information

Amlodipine / Valsartan Mylan : EPAR - Product Information

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Latest procedure affecting product information: N/0020

14/08/2023

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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).

Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations

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Product details

Name of medicine
Amlodipine / Valsartan Mylan
Active substance
  • Amlodipine besilate
  • valsartan
International non-proprietary name (INN) or common name
  • amlodipine
  • valsartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DB01

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Authorisation details

EMA product number
EMEA/H/C/004037

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Mylan Pharmaceuticals Limited

Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Opinion adopted
28/01/2016
Marketing authorisation issued
22/03/2016
Revision
11

Assessment history

Amlodipine / Valsartan Mylan : EPAR - Procedural steps taken and scientific information after authorisation

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

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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

Amlodipine / Valsartan Mylan : EPAR - Scientific conclusions

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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report

Amlodipine / Valsartan Mylan : EPAR - Public assessment report

CHMP summary of opinion for Amlodipine-Valsartan Mylan

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