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
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ENTOCORT has been granted marketing authorisation in remission induction treatment in patients suffering from active microscopic colitis.
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Its efficacy is suggested by data of poor methodological quality, particularly in lymphocytic colitis.
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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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