Mysildecard (sildenafil)
- Region
- 🇪🇺 EU
- Active substance
- sildenafil
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Thu 15 Sep 2016
- Designations
- Generic
- Application
- EMEA/H/C/004186
- ATC
- G04BE03
- Official record
- www.ema.europa.eu
Indication
AdultsTreatment 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 populationTreatment 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).
Regulatory milestones
No milestones recorded in the last year.
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