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budesonide 3mg gastro-resistant capsules (Budenofalk)


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. 

Drug Details

Drug Name: budesonide 3mg gastro-resistant capsules (Budenofalk)
SMC Drug ID: 1043/15
Manufacturer: Dr Falk Pharma UK
Indication: Autoimmune hepatitis.
BNF Category:
Sub Category: 1.5 Chronic bowel disorders
Submission Type: Full submission
Status: Restricted
Date Advice Published: 11 May 2015