Approval · Notice of Compliance 33628 · 2024
TRIKAFTA: Notice of Compliance 33628
Issued July 12, 2024
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
- 33628
- Date
- July 12, 2024
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Change to existing indication: [TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on clinical and/or in vitro data [see 10.1 Mechanism of Action and 14 CLINICAL TRIALS].
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRIKAFTA | Not yet assigned | — |
Medicinal ingredients
- IVACAFTOR 75 MG per DOSE
- TEZACAFTOR 50 MG per DOSE
- ELEXACAFTOR 100 MG per DOSE
- IVACAFTOR 60 MG per DOSE
- IVACAFTOR 59.5 MG per DOSE
- TEZACAFTOR 40 MG per DOSE
- ELEXACAFTOR 80 MG per DOSE
- 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