Approval · Notice of Compliance 14745 · 2013
SIMPONI: Notice of Compliance 14745
Issued September 19, 2013
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 14745
- Date
- September 19, 2013
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expanded indication: sympponi is indicated in adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to, or have medical contraindiations for conventional therapy including corticosteroids, amino salucylates, azathioprine (aza) or 6-mercatopurine for: inducing and maintaining clinical response (reduction in signs and symptoms), inducing clinical remission, achieving sustaines clinical remission in indution responders, improving endoscopic appearance of the mucosa during indution
- Therapeutic class
- Tumour necrosis factor alpha inhibitor