Approval · Notice of Compliance 16360 · 2014
KALYDECO: Notice of Compliance 16360
Issued November 7, 2014
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
- 16360
- Date
- November 7, 2014
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Redesigned blister pack configuration
- Therapeutic class
- Cystic fibrosis transmembrane conductase regulator (cftr) potentiator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KALYDECO | 02397412 | Marketed |
Medicinal ingredients
- IVACAFTOR 150 MG per TAB