following a resubmission:
budesonide (Cortiment®) is accepted for restricted use within NHS Scotland.
Indication under review: in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient.
SMC restriction: for use in patients with UC who present with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide.
In two phase III studies, budesonide (Cortiment®) significantly increased combined clinical and endoscopic remission at eight weeks compared with placebo. However, there are no comparative data with other oral or rectal preparations.
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Medicine details
- Medicine name:
- budesonide (Cortiment)
- SMC ID:
- 1093/15
- Indication:
- in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient.
- Pharmaceutical company
- Ferring Pharmaceuticals Ltd
- BNF chapter
- Gastro-intestinal system
- Submission type
- Resubmission
- Status
- Restricted
- Date advice published
- 10 October 2016