Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 09 August 2018

Indication(s)

- Revatio 20 mg film-coated tablets
- Revatio 10 mg/ml powder for oral suspension:


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.



- Revatio 0.8 mg/ml solution for injection:

Revatio solution for injection is for the treatment of adult patients (≥ 18 years) 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.

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More information

Category Value
Agency product number EMEA/H/C/000638
Orphan designation No
Date First Approved 28-10-2005
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Pfizer Europe MA EEIG