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EMA Product

Duloxetine Mylan

Product approved by European Medicines Agency (EU)

Basic Information

Duloxetine Mylan

Regulatory Information

EMEA/H/C/003981

Authorised

June 19, 2015

April 23, 2015

21

June 20, 2024

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15

VIATRIS PHARMA LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication - Treatment of major depressive disorder; - Treatment of diabetic peripheral neuropathic pain; - Treatment of generalised anxiety disorder; - Duloxetine Mylan is indicated in adults.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Duloxetine 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 Duloxetine Mylan. For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

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