REVATIO

The actual benefit offered by REVATIO proprietary medicinal products is moderate.

The use of extemporaneous preparations from sildenafil tablets is part of clinical practice, and this use is justified by the few treatment alternatives suitable for use in paediatrics. The pharmaceutical forms available and developed for REVATIO proprietary medicinal products meet the quality and safety requirements for administration to children and adolescents. However, in the absence of data with a sufficient level of evidence, the Transparency Committee considers that :

- REVATIO 20 mg, film-coated tablet, does not offer any improvement in actual benefit (IAB V) in the management of pulmonary arterial hypertension in children and adolescents aged from 1 to 17 years suffering from PAH,

- REVATIO 10 mg/ml, powder for oral suspension, is an addition to the range which is useful for the treatment of PAH in children and adolescents aged from 1 to 17 years suffering from PAH and in adults unable to swallow film-coated tablets.