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.
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\).
Therapeutic Area (MeSH)
ATC Code
G04BE03
ATC Item
N/A
Pharmacotherapeutic Group
Urologicals
Active Substance (Summary)
INN / Common Names
EMA Name
Mysildecard
Medicine Name
Mysildecard
Aliases
N/ANo risk management plan link.
