Approval · Notice of Compliance 33737 · 2024
TRACLEER: Notice of Compliance 33737
Issued July 30, 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
- 33737
- Date
- July 30, 2024
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety information. Product Monograph reformatted to the Master Template
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRACLEER | Not yet assigned | — |
Medicinal ingredients
- BOSENTAN MONOHYDRATE 62.5 MG per TAB
- BOSENTAN MONOHYDRATE 125 MG per TAB