Revatio
sildenafil
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Revatio. 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 Revatio.
For practical information about using Revatio, patients should read the package leaflet or contact their doctor or pharmacist.
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List item
Revatio : EPAR - Summary for the public (PDF/73 KB)
First published: 17/08/2009
Last updated: 21/11/2016 -
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List item
Revatio : EPAR - Risk management plan summary (PDF/124.13 KB)
First published: 15/09/2021
Authorisation details
Product details | |
---|---|
Name |
Revatio
|
Agency product number |
EMEA/H/C/000638
|
Active substance |
sildenafil
|
International non-proprietary name (INN) or common name |
sildenafil
|
Therapeutic area (MeSH) |
Hypertension, Pulmonary
|
Anatomical therapeutic chemical (ATC) code |
G04BE03
|
Publication details | |
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Marketing-authorisation holder |
Upjohn EESV
|
Revision |
50
|
Date of issue of marketing authorisation valid throughout the European Union |
28/10/2005
|
Contact address |
Rivium Westlaan 142 |
Product information
26/09/2023 Revatio - EMEA/H/C/000638 - N/0106
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 adult patients with pulmonary arterial hypertension classified as World Health Organization (WHO) functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Paediatric population
Treatment of paediatric patients aged one year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.
Revatio solution for injection is for the treatment of adult patients with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Revatio (oral) is indicated for treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.