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ENTYVIO (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
ENTYVIO
Date registered
Evaluation commenced
Decision date
Approval time
80 (120 working days)
Active ingredients
vedolizumab
Registration type
EOI
Indication
Pouchitis
ENTYVIO / KYNTELES is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.