Revatio (sildenafil)
- Region
- 🇪🇺 EU
- Active substance
- sildenafil
- Company
- Viatris EESV
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Wed 27 Jul 2005
- EU approval
- Fri 28 Oct 2005
- Application
- EMEA/H/C/000638
- ATC
- G04BE03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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