Amlodipine / Valsartan Mylan

amlodipine / valsartan

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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.

What is Amlodipine/Valsartan Mylan and what is it used for?

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.

How is Amlodipine/Valsartan Mylan used?

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.

How does Amlodipine/Valsartan Mylan work?

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.

How has Amlodipine/Valsartan Mylan been studied?

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.

What are the benefits and risks of Amlodipine/Valsartan Mylan?

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.

Why is Amlodipine/Valsartan Mylan approved?

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.

What measures are being taken to ensure the safe and effective use of Amlodipine/Valsartan Mylan?

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.

Other information about Amlodipine/Valsartan Mylan

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.

Name Language First published Last updated
Amlodipine / Valsartan Mylan : EPAR - Summary for the public BG = bălgarski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public ES = español 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public CS = čeština 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public DA = dansk 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public DE = Deutsch 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public ET = eesti keel 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public EL = elliniká 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public EN = English 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public FR = français 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public IT = italiano 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public LV = latviešu valoda 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public LT = lietuvių kalba 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public HU = magyar 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public MT = Malti 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public NL = Nederlands 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public PL = polski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public PT = português 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public RO = română 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public SK = slovenčina 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public SL = slovenščina 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public FI = suomi 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public SV = svenska 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - Summary for the public HR = Hrvatski 2016-04-06  

This EPAR was last updated on 06/02/2017 .

Authorisation details

Product details

Product details for Amlodipine / Valsartan Mylan
NameAmlodipine / Valsartan Mylan
Agency product numberEMEA/H/C/004037
Active substance

amlodipine besilate / valsartan

International non-proprietary name (INN) or common name

amlodipine / valsartan

Therapeutic area Hypertension
Anatomical therapeutic chemical (ATC) code C09DB01
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Amlodipine / Valsartan Mylan
Marketing-authorisation holder

Mylan S.A.S

Revision1
Date of issue of marketing authorisation valid throughout the European Union22/03/2016

Contact address:

Mylan S.A.S
117 Allée des Parcs 
69800 Saint Priest 
France

Product information

Product information

11/11/2016  Amlodipine / Valsartan Mylan -EMEA/H/C/004037 -IAIN-0002

Name Language First published Last updated
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06
Amlodipine / Valsartan Mylan : EPAR - Product Information HR = Hrvatski 2016-04-06 2017-02-06

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
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  
Amlodipine / Valsartan Mylan : EPAR - All Authorised presentations HR = Hrvatski 2016-04-06  

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Amlodipine / Valsartan Mylan : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-02-06  

Initial marketing-authorisation documents

Name Language First published Last updated
Amlodipine / Valsartan Mylan : EPAR - Public assessment report HR = Hrvatski 2016-04-06  
CHMP summary of opinion for Amlodipine-Valsartan Mylan HR = Hrvatski 2016-01-29  

Authorised

This medicine is approved for use in the European Union

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