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sildenafil (Revatio)

Advice

Following an abbreviated submission:

sildenafil (Revatio®) is accepted for restricted use within NHS Scotland.

Indication under review: 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.

SMC restriction: restricted to use on the advice of specialists in the Scottish Pulmonary Vascular Unit and from the Scottish Adult Congenital Cardiac Service.

SMC has previously accepted this orphan indication for oral sildenafil for restricted use within NHS Scotland for the 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.

Sildenafil is listed in the British National Formulary for Children 2011-2012 for use in pulmonary hypertension after cardiac surgery, weaning from nitric oxide, idiopathic pulmonary arterial hypertension, persistent pulmonary hypertension of the newborn.

Drug Details

Drug Name: sildenafil (Revatio)
SMC Drug ID: 809/12
Manufacturer: Pfizer Ltd
Indication: For the 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.
BNF Category:
Sub Category: 2.5 Hypertension and heart failure
Submission Type: Abbreviated Submission
Status: Restricted
Date Advice Published: 10 December 2012

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