PERPRUP (povidone-iodine, isopropyl alcohol) - Antiseptic

The clinical benefit of PERPRUP (povidone-iodine, isopropyl alcohol) 7.25 mg/ml + 633 mg/ml solution for cutaneous application is substantial in the MA indication.

Considering:

• the medical need partially met by alcohol solutions containing povidone-iodine and chlorhexidine given the care-related infections that occur despite the use of these antiseptic solutions,
• data relative to the PREVAIL-FX proprietary medicinal product, solution containing 8.3% povidone-iodine and 72.5% isopropyl alcohol (antiseptic solution with the same composition as PERPRUP but non-sterile) contained in an applicator device similar to that of PERPRUP, derived from the SUR-19IPVPV01 prospective study conducted on healthy skin prior to an invasive medical procedure, demonstrating a reduction in the number of cutaneous micro-organisms on the abdomen and the groin compared to the baseline value higher than the expected activity standards, 10 minutes and 6 hours after application to the skin,

but:

• the lack of evidence of the efficacy of PERPRUP on a relevant clinical endpoint, such as reduction of the incidence of postoperative site infections,
• the lack of robust comparative data versus the available alternatives France,

the Committee deems that PERPRUP (iodine povidone, isopropyl alcohol) 7.25 mg/ml + 633 mg/ml solution for cutaneous application provides no clinical added value (CAV V) compared to the other available antiseptic alcohol solutions containing povidone-iodine.