Approval · Notice of Compliance 33789 · 2024
SPEVIGO: Notice of Compliance 33789
Issued July 31, 2024
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
- 33789
- Date
- July 31, 2024
- Company
- Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expansion of indication: Spevigo (spesolimab injection/ spesolimab for injection) is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. Addition of a new strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SPEVIGO | Not yet assigned | — |
| SPEVIGO | 02550296 | Marketed |
Medicinal ingredients
- SPESOLIMAB 60 MG per ML
- SPESOLIMAB 150 MG per ML