The Committee considers that the actual benefit of the proprietary medicinal product TADIM in the Marketing Authorisation indication is :
- substantial within the context of its administration with a "conventional" nebuliser system requiring a pneumatic generator (Pari LC system).
Insufficient
- insufficient within the context of its administration with theportable nebuliser system fitted with "AAD" and "VMT" (I neb AAD system) technologies or the Respironics Sidestream system with a Portaneb compressor.
Clinical Added Value
no clinical added value
TADIM does not provide an improvement in actual benefit (IAB V,non-existent) compared with COLIMYCIN 1 MIU nebuliser solution.