Advice
following a full submission
budesonide (Budenofalk®) is accepted for restricted use within NHS Scotland.
Indication under review: autoimmune hepatitis.
SMC restriction: for use in non-cirrhotic patients who are intolerant of conventional oral corticosteroids (prednisolone) with severe corticosteroid-related side effects (actual or anticipated) such as psychosis, poorly controlled diabetes or osteoporosis
In a phase IIb study, a significantly greater proportion of patients with non-cirrhotic autoimmune hepatitis achieved complete biochemical remission and a reduction in predefined corticosteroid-specific side effects when treated with budesonide plus an immunosuppressant compared with an alternative corticosteroid plus an immunosuppressant.
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Medicine details
- Medicine name:
- budesonide 3mg gastro-resistant capsules (Budenofalk)
- SMC ID:
- 1043/15
- Indication:
- Autoimmune hepatitis.
- Pharmaceutical company
- Dr Falk Pharma UK
- BNF chapter
- Gastro-intestinal system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 11 May 2015