Approval · Notice of Compliance 15707 · 2014
KALYDECO: Notice of Compliance 15707
Issued June 6, 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
- 15707
- Date
- June 6, 2014
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- To expand the indication for kalydeco (ivacaftor) for people with cystic fibrosis ages 6 and older who have one of nine additional mutations in the cf transmembrane conductance regulator (cftr) gene
- Therapeutic class
- Cystic fibrosis transmembrane conductance regulator (cftr) potentiator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KALYDECO | Not yet assigned | — |
Medicinal ingredients
- IVACAFTOR 150 MG per TAB