Approval · Notice of Compliance 26502 · 2021
KALYDECO: Notice of Compliance 26502
Issued August 25, 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
- 26502
- Date
- August 25, 2021
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Addition of new 25 mg strength and to expand the indication
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KALYDECO | Not yet assigned | — |
| KALYDECO | 02519364 | Marketed |