Approval · Notice of Compliance 18169 · 2016
INFLECTRA: Notice of Compliance 18169
Issued June 10, 2016
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
- 18169
- Date
- June 10, 2016
- Company
- Celltrion Healthcare Co Ltd
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- NEW INDICATIONS: iNFLECTRA (INFLIXIMAB) IS INDICATED FOR: REDUCTIO OF SIGNS AND SYMPTOMS, INDUCTION AND MAINTENANCE OF CLINICAL REMISSION AND MUCOSAL HEALING AND REDUCTIO OF CORTICOSTEROID USE IN ADULT PAITENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE REPONSE TO A CORTICOSTEROID AND.OR AMINOSALICYLATE. INFLECTRA CAN BE USED ALONE OR IN COMBINATION WITH CONVENTIONAL THERAPY. TREATEMENT OF FISTULATING CROHN'S DISEASE IN ADULT PATIENTS WHO HAVE NOT RESPONDED DESPITE A FULL AND ANDEQUATE COURSE OF THERAPY WITH CONVENTIONAL TREATMENT. REDUCTION OF SIGNS AND SYMPTOMS, INDUCTION AND MAINTENANCE OF CLINICAL REMISSION AND MUCOSAL HEALING AND REDUCTION OR ELIMINATION OF CORTICOSTEROID USE IN ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INDADEQUATE RESPONSE TO CONVENTIONAL THERAPY (IE. AMINOSALICYLATE AND/OR CORTICOSTEROIND AN/OR AN IMMUNOSUPPRESSANT).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFLECTRA | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL