Approval · Notice of Compliance 19051 · 2017
ENBREL: Notice of Compliance 19051
Issued March 14, 2017
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
- 19051
- Date
- March 14, 2017
- Company
- Immunex CorporationThousand Oaks, California, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (jia) in patients aged 4 to 17 years who have had an inadequate reponse to one or more disease-modifying antirheumatic drugs (dmards). enbrel has not been studied in children less tha 2 years of age. treatment od peidatricd patients ages 4 to 17 years with chronic severe pso who are candidates for sytemic therapy or phototherapy. data on safety and efficacy are limited in the age group 4 to 6 years. improvement may be seen as early as 1 week after initial administration of enbrel in adults, and within 2 weeks in children with jia and 4 weeks in psoriasis. attainment of wull effect was usualy seen by 3 months in both populations and remained durable therafter with continuing improvement after 3 monthe of treatment with enbrel. after discontinuation of enbrel symptoms of arthritis generally returned within a month. reintroduction of treatment with enbrel in adults after discontinuation of up to 18 months resulted in the same magnitudes of response as patients who received enbrel without interruption of therapy based on results of open-label studies. reintroduction of enbrel to children with jia after discontinuation of up to 4 monthe also resulted in a subsequent response to therapy. enbrel has not been studied in children <2 years of age. enbrel has been studied in the treatment of polyarticular jia in patients ages 2 to 17 who have had an inadequte response to one or more dmards, and in patients age3s 4 to 17 with chronic pso who are candidates for systemic therapy or phototherapy. data on safety and efficacy in pso patients are limited in the age group 4 to 6 years.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ENBREL | Not yet assigned | — |
Medicinal ingredients
- ETANERCEPT 25 MG per VIAL
- ETANERCEPT 25 MG per ML
- ETANERCEPT 50 MG per ML