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Opinions on drugs - Posted on Mar 06 2014

Reason for request



Clinical Benefit


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 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.