Approval · Notice of Compliance 27994 · 2022
TRIKAFTA: Notice of Compliance 27994
Issued April 20, 2022
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
- 27994
- Date
- April 20, 2022
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Expansion of Indication age range. Addition of new strength.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRIKAFTA | 02526670 | Marketed |
Medicinal ingredients
- IVACAFTOR 37.5 MG per TAB
- IVACAFTOR 75 MG per TAB
- TEZACAFTOR 25 MG per TAB
- ELEXACAFTOR 50 MG per TAB