Approval · Notice of Compliance 16140 · 2013
ILARIS: Notice of Compliance 16140
Issued July 10, 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
- 16140
- Date
- July 10, 2013
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised indicationm: ilaris is indicated for the ongoing management of cryopyrin-associated periodic syndromes (caps) in adults and children aged 2 years and older including: familial cold autoinflammatory syndrome (fcas), familial cold urticaria (fcu), muckle-wells syndrome (mwsd). ilaris may also be used in neonatal-onset multysystem inflammatory disease (nomid),. chronic infantile neurological cutaneous articular syndrome (cinca),. clinical data have not confirmed improvement in cns symptoms in patients with this phenotype
- Therapeutic class
- Anti-inflammatory
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ILARIS | Not yet assigned | — |
Medicinal ingredients
- CANAKINUMAB 150 MG per VIAL