REVATIO - REVATIO - CT 6330 - English version

REVATIO - REVATIO - CT 6330 - English version


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Introduction REVATIO 20 mg, film-coated tablets B/90 (CIP code: 370 240-6) Posted on Jan 05 2011 Active substance (DCI) sildenafil Pneumologie - Mise au point Progrès thérapeutique : – important pour FLOLAN ; – modéré pour TRACLEER ; – mineur pour ADCIRCA, REMODULIN, REVATIO, VENTAVIS et VOLIBRIS Les médicaments de l’hypertension artérielle pulmonaire (HTAP) n'apportent qu'un bénéfice symptomatique, et celui-ci est modeste. FLOLAN (époprosténol) est le seul ayant montré une augmentation de la survie. Son rapport efficacité/effets indésirables est donc important ; il est modéré pour les autres médicaments. Il s’agit de médicaments de première intention, excepté REMODULIN et VENTAVIS, qui sont utilisés en deuxième intention. N.B. – THELIN a été retiré du marché en raison de son risque d'atteinte hépatique sévère. Pour en savoir plus télécharger la synthèse ou l'avis complet ci-dessous ATC Code G04BE03 Laboratory / Manufacturer PFIZER REVATIO 20 mg, film-coated tablets B/90 (CIP code: 370 240-6) Posted on Jan 05 2011



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Published 05 January 2011
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The legally binding text is the original French version  TRANSPARENCY COMMITTEE
 OPINION  5 January 2011   REVATIO 20 mg, film-coated tablets B/90 (CIP code: 370 240-6)   Applicant: PFIZER  sildenafil ATC code: G04BE03  List I Medicine for hospital prescription only, restricted to specialists and/or departments specialising in pneumology, cardiology, or internal medicine.  Date of Marketing Authorisation (centralised procedure): 28 October 2005 Orphan drug (date of designation: 12 December 2003 for sildenafil in the treatment of PAH)  Reason for examination:  Reassessment of actual clinical benefit and improvement in actual clinical benefit under -article R-163-21 of the Social Security Code. - Inclusion in the extension of indication for patients in functional class II.  Indications:  “Treatment of patients with pulmonary arterial hypertension classified as WHO functional class II or III, to improve exercise capacity. Efficacy has been shown in idiopathic pulmonary arterial hypertension and pulmonary arterial hypertension associated with a connective tissue disease.”  Dosage: see SPC  The Transparency Committee has reassessed all treatments for PAH. Distinctions have been drawn between the various drugs (see complete report attached). The Transparency Committee’s conclusions regarding REVATIO were as follows:          
Actual clinical benefit PAH is a rare pulmonary condition that affects life expectancy. It is characterised by gradual blocking of the small pulmonary arteries, leading to a gradual increase in pulmonary arterial pressure and right cardiac insufficiency. PAH is defined by an increase in mean pulmonary arterial pressure (mPAP) measured by right cardiac catheterisation which is equal to or greater than 25 mmHg at rest, with no increase in pulmonary capillary pressure. Asthenia, dyspnoea, chest pain and loss of consciousness are the most frequent clinical signs. Median survival under symptomatic treatment is around 2.5 years for patients with functional class III PAH and 4.8 years for those with functional class II PAH. All treatments for PAH are in the symptomatic category. The efficacy/adverse effects ratio is moderate. This medicinal product is a first-line therapy. No public health benefit is expected. The actual clinical benefit is moderate.  Improvement in actual clinical benefit (IAB) The Transparency Committee considers that the proprietary drug REVATIO provides a minor improvement in actual clinical benefit (IAB IV) in the treatment of idiopathic pulmonary arterial hypertension, or pulmonary arterial hypertension associated with systemic collagen disease, for patients in functional class II or III.  The Transparency Committee expresses the wish, at the request of the Directorate General for Health, that proprietary drugs administered per os route be made available for delivery on retail pharmacies.            Medical, Economic and Public Health Assessment Division