Approval · Notice of Compliance 16690 · 2015
KALYDECO: Notice of Compliance 16690
Issued March 13, 2015
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
- 16690
- Date
- March 13, 2015
- 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 of kalydeco for the treatment of cystic fibrosis in patients 18 years and older who have an R117h nutation in the 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