Approval · Notice of Compliance 26648 · 2021
NUCALA: Notice of Compliance 26648
Issued September 14, 2021
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
- 26648
- Date
- September 14, 2021
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication : Nucala is indicated as an add-on to standard therapy for the treatment of adult patients with hypereosinophilic syndrome (HES) for ¿6 months without an identifiable non-hematologic secondary cause.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NUCALA | Not yet assigned | — |
Medicinal ingredients
- MEPOLIZUMAB 100 MG per VIAL
- MEPOLIZUMAB 100 MG per ML
- MEPOLIZUMAB 100 MG per SYR