Basic Information
Mysildecard
Regulatory Information
EMEA/H/C/004186
September 15, 2016
July 21, 2016
9
May 21, 2024
Company Information
Ireland
Damastown Industrial Park Dublin 15
VIATRIS PHARMA LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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).
Overview Summary
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.