Tadalafil Mylan

RSS

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 28/09/2021

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
GenericGeneric

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
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
21/11/2014
Contact address

Mylan Pharmaceuticals Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
Ireland

Product information

15/09/2021 Tadalafil Mylan - EMEA/H/C/003787 - T/0020

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

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

How useful was this page?

Add your rating
Average
24 ratings
23 ratings
15 ratings
29 ratings