ENTOCORT (budesonide), locally acting corticosteroid
GASTROENTEROLOGY - New indication
Opinions on drugs -
Posted on
Oct 24 2018
Reason for request
Extension of indication
High clinical benefit in active microscopic colitis, but no demonstrated clinical benefit in the therapeutic strategy
ENTOCORT has been granted marketing authorisation in remission induction treatment in patients suffering from active microscopic colitis.
Its efficacy is suggested by data of poor methodological quality, particularly in lymphocytic colitis.
It has not been compared to MIKICORT, another budesonide-based medicinal product having been granted marketing authorisation in collagenous colitis, or to other symptomatic treatments used off-label in practice (loperamide, 5 ASA, cholestyramine, etc.).
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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