Mysildecard

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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 Mysildecard. 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 Mysildecard.

For practical information about using Mysildecard, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 04/07/2022

Authorisation details

Product details
Name
Mysildecard
Agency product number
EMEA/H/C/004186
Active substance
sildenafil citrate
International non-proprietary name (INN) or common name
sildenafil
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
G04BE03
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Viatris Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
15/09/2016
Contact address

Damastown Industrial Park 
Mulhuddart  
Dublin 15 
DUBLIN  
Ireland

Product information

01/07/2022 Mysildecard - EMEA/H/C/004186 - IB/0012

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

Adults
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.

Paediatric population
Treatment of paediatric patients aged 1 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 (see section 5.1).

Assessment history

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