Approval · Notice of Compliance 31866 · 2023
TRIKAFTA: Notice of Compliance 31866
Issued October 16, 2023
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
- 31866
- Date
- October 16, 2023
- Company
- Vertex Pharmaceuticals (Canada) IncorporatedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Expand indication. Addition of new dosage form . Addition of new strengths
Products in this notice
Medicinal ingredients
- IVACAFTOR 75 MG per TAB
- IVACAFTOR 150 MG per TAB
- TEZACAFTOR 50 MG per TAB
- ELEXACAFTOR 100 MG per TAB
- IVACAFTOR 37.5 MG per TAB
- TEZACAFTOR 25 MG per TAB
- ELEXACAFTOR 50 MG per TAB
- IVACAFTOR 75 MG per GRA
- TEZACAFTOR 50 MG per GRA
- ELEXACAFTOR 100 MG per GRA
- IVACAFTOR 59.5 MG per GRA
- IVACAFTOR 60 MG per GRA
- TEZACAFTOR 40 MG per GRA
- ELEXACAFTOR 80 MG per GRA