Approval · Notice of Compliance 8015 · 2006
REMICADE: Notice of Compliance 8015
Issued June 7, 2006
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
- 8015
- Date
- June 7, 2006
- Company
- Centocor Inc.Leiden, --, Netherlands
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indications: 1) reduction of signs and symptoms, induction of major clinical response, inhibition of the progression of structural damage of active arthritis, and improvement in physical function in patients with psoriatic arthritis. 2) treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidate for systemic therapy
- Therapeutic class
- Biological response modifier
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMICADE | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL