Cialis

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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 24/05/2017

Authorisation details

Product details
Name
Cialis
Agency product number
EMEA/H/C/000436
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
26
Date of issue of marketing authorisation valid throughout the European Union
12/11/2002
Contact address
Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

23/03/2017 Cialis - EMEA/H/C/000436 - WS/1066

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 order for tadalafil to be effective, sexual stimulation is required.

Cialis is not indicated for use by women.

Assessment history

Changes since initial authorisation of medicine

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