Adcirca (previously Tadalafil Lilly)
tadalafil
Table of contents
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.
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 | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
01/10/2008
|
Contact address |
Papendorpseweg 83 |
Product information
28/01/2021 Adcirca (previously Tadalafil Lilly) - EMEA/H/C/001021 - WS/1940
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
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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.