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Azathioprine does not have a specific FDA or EMA marketing authorization for ulcerative colitis; it is not formally labeled for this indication in the US or Europe, despite being established and recommended in clinical guidelines for maintenance of remission in steroid-dependent or refractory UC. The approvals and official labeling of azathioprine are for use as an immunosuppressant in various diseases, but clinical consensus and real-world practice support its use for UC maintenance therapy based on longstanding evidence and experience
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