Approval · Notice of Compliance 22578 · 2019
INFLECTRA: Notice of Compliance 22578
Issued August 28, 2019
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
- 22578
- Date
- August 28, 2019
- Company
- Celltrion Healthcare Co Ltd
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- NEW INDICATIONS: REDDUCTION OF SIGNS AND SYMPTOMS AND INDUCITON AND MAINTENANCE OF CLINICAL REMISSION INPEDIATRIC PATIENTS WITH MODERATELY TO SEVERE ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPY (CORTICOSTEROID AND/OR AMINOSILICYOLATE AND/OR IMMUNOSUPPRESSANT). THE SAFETY AND EFFICACY OF INFLECTRA IS NOT ESTABLISHED IN PATIENTS LESS THAN 9 YEARS OF AGE. REDUCTION OF SIGNS AND SYMPTOMS, INDUCTION AND MAINTENANCE OF CLINICAL REMISSION, AND INDUCTION OF MUCOSAL HEALING IN PEDIATRIC PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPY (IE AMINOSALICYLATE AND/OR CORTICOSTEROID AND/OR IMMUNOSUPPRESSANT). thE SWAFETY AND EFFICACY OF INFLECTRA HAVE NOT BEEN ESTABLISHED IN PATIENTS LESS THA 6 YEARS OF AGE.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INFLECTRA | Not yet assigned | — |
Medicinal ingredients
- INFLIXIMAB 100 MG per VIAL