Approval · Notice of Compliance 34985 · 2025
KALYDECO: Notice of Compliance 34985
Issued March 11, 2025
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
- 34985
- Date
- March 11, 2025
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a drug product manufacturing site and/or manufacturer involving production. Change in the approved design space
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KALYDECO | Not yet assigned | — |
Medicinal ingredients
- IVACAFTOR 150 MG per TAB