Tadalafil Lilly

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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 Lilly. 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 Lilly.

For practical information about using Tadalafil Lilly, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 21/09/2023

Authorisation details

Product details
Name
Tadalafil Lilly
Agency product number
EMEA/H/C/004666
Active substance
tadalafil
International non-proprietary name (INN) or common name
tadalafil
Therapeutic area (MeSH)
Erectile Dysfunction
Anatomical therapeutic chemical (ATC) code
G04BE08
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

23/08/2023 Tadalafil Lilly - EMEA/H/C/004666 - PSUSA/00002841/202210

Other EU languages available icon 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:

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 Lilly is not indicated for use by women.

Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Assessment history

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