Approval · Notice of Compliance 37468 · 2026
TRIKAFTA: Notice of Compliance 37468
Issued May 1, 2026
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
- 37468
- Date
- May 1, 2026
- 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 (Hovione LLC) and/or manufacturer involving production. Addition of a drug product manufacturing site (Patheon) and/or manufacturer involving production. Change in the drug product manufacturing process (Patheon)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRIKAFTA | Not yet assigned | — |
Medicinal ingredients
- IVACAFTOR 37.5 MG per TAB
- IVACAFTOR 75 MG per TAB
- TEZACAFTOR 25 MG per TAB
- ELEXACAFTOR 50 MG per TAB
- IVACAFTOR 150 MG per TAB
- TEZACAFTOR 50 MG per TAB
- ELEXACAFTOR 100 MG per TAB