IZINOVA (sodium sulfate, magnesium sulfate, potassium sulfate), bowel-cleansing preparation
HEPATO-GASTRO-ENTEROLOGY - New medicinal product
Opinions on drugs - Posted on Jan 20 2015
Reason for request
No clinical added value demonstrated in bowel cleansing by comparison with preparations containing PEG
- IZINOVA has Marketing Authorisation in adults for bowel cleansing prior to all procedures requiring a clean bowel.
- It has shown its non-inferiority in terms of efficacy in comparison with MOVIPREP taken in a single- or split-dose regimen, and its superiority in comparison with PICOREP taken in a split-dose regimen.
The actual benefit of IZINOVA in the Marketing Authorisation indications is substantial.
Clinical Added Value
|no clinical added value||
IZINOVA provides no improvement in actual benefit (level V, non-existent) in bowel cleansing, compared with conventional PEG-based bowel preparations.