Approval · Notice of Compliance 21089 · 2018
NUCALA: Notice of Compliance 21089
Issued July 17, 2018
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
- 21089
- Date
- July 17, 2018
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: eosinophilic granulomatosis with polyangiitis. nucala (mepolizumab for injection) is indicated as an add-on to corticosteroids for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (egpa)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NUCALA | Not yet assigned | — |
Medicinal ingredients
- MEPOLIZUMAB 144 MG per VIAL