MIKICORT (budesonide), corticosteroid for local use

HEPATOLOGY - New indication
Opinions on drugs - Posted on Nov 10 2016

Reason for request

Extension of indication

No clinical benefit demonstrated in the management of autoimmune hepatitis when compared with systemic corticosteroids

 

  • MIKICORT has obtained an extension of indication in the induction of remission and the maintenance treatment for autoimmune hepatitis.
  • Data on long-term tolerability and efficacy are limited.
  • Its use in combination with azathioprine should be reserved for noncirrhotic patients with a relative contraindication to systemic corticosteroid therapy or to corticosteroid replacement therapy in the event of the onset of adverse effects.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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