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EMA Product

Amlodipine / Valsartan Mylan

Product approved by European Medicines Agency (EU)

Basic Information

Amlodipine / Valsartan Mylan

Regulatory Information

EMEA/H/C/004037

Authorised

March 22, 2016

January 28, 2016

15

May 12, 2025

Company Information

Ireland

Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN

MYLAN PHARMACEUTICALS PRIVATE LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Amlodipine besilatevalsartan

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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.

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