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EMA Product

Tadalafil Mylan

Product approved by European Medicines Agency (EU)

Basic Information

Tadalafil Mylan

Regulatory Information

EMEA/H/C/003787

Authorised

November 21, 2014

17

January 24, 2025

Company Information

Ireland

Damastown Industrial Park Mulhuddart Dublin 15

MYLAN PHARMACEUTICALS PRIVATE LIMITED

Drug Classification

Generic Medicine

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.

Overview Summary

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

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