Amlodipine / Valsartan Mylan


amlodipine / valsartan

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 30/09/2022

Authorisation details

Product details
Amlodipine / Valsartan Mylan
Agency product number
Active substance
  • Amlodipine besilate
  • valsartan
International non-proprietary name (INN) or common name
  • amlodipine
  • valsartan
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code

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.

Publication details
Marketing-authorisation holder
Mylan Pharmaceuticals Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,

Product information

29/09/2022 Amlodipine / Valsartan Mylan - EMEA/H/C/004037 - IAIN/0018

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Product information documents contain:

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.

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

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