Quote this publication Share Print

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

Inclusion

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.

Clinical Benefit

Substantial

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.