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APO-MESALAZINE MR, MESALAZINE RMB, MESALAZINE SCP, MESALAZINE TLB (Southern Cross Pharma Pty Ltd)
Product name
APO-MESALAZINE MR, MESALAZINE RMB, MESALAZINE SCP, MESALAZINE TLB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 (255 working days)
Active ingredients
mesalazine
Registration type
New generic medicine
Indication
APO-MESALAZINE MR, MESALAZINE RMB, MESALAZINE SCP, MESALAZINE TLB (modified release tablet) is indicated for the induction and maintenance of remission in patients with mild to moderate, active ulcerative colitis.