Approval · Notice of Compliance 32204 · 2023
KALYDECO: Notice of Compliance 32204
Issued November 28, 2023
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
- 32204
- Date
- November 28, 2023
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Expansion of indication. Addition of new strength Updates to the Product Monograph. Updates to labels. Updates to package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KALYDECO | Not yet assigned | — |
| KALYDECO | 02543451 | Marketed |