Adcirca (previously 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 Adcirca. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcirca.

This EPAR was last updated on 24/05/2017

Authorisation details

Product details
Name
Adcirca (previously Tadalafil Lilly)
Agency product number
EMEA/H/C/001021
Active substance
tadalafil
International non-proprietary name (INN) or common name
tadalafil
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
G04BE08
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
30/09/2008
Contact address

Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

23/03/2017 Adcirca (previously Tadalafil Lilly) - EMEA/H/C/001021 - 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

Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization functional class II and III, to improve exercise capacity (see section 5.1).

Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Assessment history

Changes since initial authorisation of medicine

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