Revatio

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sildenafil

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 20/11/2023

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
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 
Capelle aan den Ijssel
2909 LD
Netherlands

Product information

26/09/2023 Revatio - EMEA/H/C/000638 - N/0106

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 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.

Assessment history

Changes since initial authorisation of medicine

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