Tadalafil Mylan
tadalafil
Table of contents
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.
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Tadalafil Mylan : EPAR - Summary for the public (PDF/92.82 KB)
First published: 19/12/2014
Last updated: 19/12/2014 -
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Tadalafil Mylan : EPAR - Risk-management-plan summary (PDF/45.33 KB)
First published: 19/12/2014
Last updated: 19/12/2014
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 and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Mylan S.A.S.
|
Revision |
11
|
Date of issue of marketing authorisation valid throughout the European Union |
21/11/2014
|
Contact address |
Product information
11/12/2019 Tadalafil Mylan - EMEA/H/C/003787 - IAIN/0017
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.