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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.

Actual benefit

Important

The actual benefit of IZINOVA in the Marketing Authorisation indications is substantial.


Improvement in actual benefit

V (absence)

IZINOVA provides no improvement in actual benefit (level V, non-existent) in bowel cleansing, compared with conventional PEG-based bowel preparations.