Tadalafil Mylan

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tadalafil

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 17/08/2018

Authorisation details

Product details
Name
Tadalafil Mylan
Agency product number
EMEA/H/C/003787
Active substance
tadalafil
International non-proprietary name (INN) or common name
tadalafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE08
Generic

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 medicines.

Publication details
Marketing-authorisation holder
Mylan S.A.S.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
21/11/2014
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

03/08/2018 Tadalafil Mylan - EMEA/H/C/003787 - T/0011

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.

Pharmacotherapeutic group

UROLOGICALS

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.

Assessment history

Changes since initial authorisation of medicine

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