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VENTAVIS - VENTAVIS - CT 6292 - English version

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Introduction VENTAVIS 10 microgram/ml nebuliser solution B/30 x 1 ml (CIP code: 375 480-5) B/30 x 2 ml (CIP code: 564 920-2) Posted on Jan 05 2011 Active substance (DCI) iloprost 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 B01AC11 Laboratory / Manufacturer BAYER SANTE VENTAVIS 10 microgram/ml nebuliser solution B/30 x 1 ml (CIP code: 375 480-5) B/30 x 2 ml (CIP code: 564 920-2) Posted on Jan 05 2011
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 The legally binding text is the original French version  TRANSPARENCY COMMITTEE
 OPINION  5 January 2011   VENTAVIS 10 microgram/ml nebuliser solution B/30 x 1 ml (CIP code: 375 480-5) B/30 x 2 ml (CIP code: 564 920-2)   Applicant: BAYER SANTE  iloprost ATC code: B01AC11  List I Medicine for hospital prescription only, restricted to specialists and/or departments specialising in pneumology or cardiology  Marketing Authorisation date for the 2 ml ampoules (centralised procedure): 16 September 2003 Marketing Authorisation date for the 1 ml ampoules (centralised procedure): 2 May 2006 MA under exceptional circumstances The results of an observational study requested by the CHMP and aimed at collecting long-term safety and efficacy data are expected for the fourth quarter of 2012. Orphan drug (designation granted on 29 December 2000)  Reason for examination: Reassessment of actual benefit and improvement in actual benefit (AB) under article R-163-21 of the Social Security Code.  Indications:  “Treatment of patients with primary pulmonary arterial hypertension, classified as WHO functional class III, to improve exercise capacity and symptoms.”  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 VENTAVIS were as follows:  
Actual 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. The median survival time for patients with PAH in functional class III receiving symptomatic treatment is around 2.5 years. All treatments for PAH are in the symptomatic category. The efficacy/adverse effects ratio is moderate. In practice, prostacyclins are used as second-line treatment. No public health benefit is expected. The actual benefit is moderate.  Improvement in actual benefit (IAB) The Transparency Committee considers that the proprietary drug VENTAVIS provides a minor improvement in actual benefit (IAB IV) in the treatment of idiopathic pulmonary arterial hypertension for patients in functional class III.            Medical, Economic and Public Health Assessment Division