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/101.67 KB) (updated)
First published: 19/12/2014
Last updated: 01/06/2023
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 | |
|---|---|
| Marketing-authorisation holder |
Mylan Pharmaceuticals Limited
|
| Revision |
15
|
| Date of issue of marketing authorisation valid throughout the European Union |
21/11/2014
|
| Contact address |
Mylan Pharmaceuticals Limited |
Product information
15/06/2022 Tadalafil Mylan - EMEA/H/C/003787 - WS/2431
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.