Approval · Notice of Compliance 23939 · 2020
OPSUMIT: Notice of Compliance 23939
Issued July 23, 2020
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
- 23939
- Date
- July 23, 2020
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add pediatric pharmacokinetic information in the Product Monograph
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPSUMIT | Not yet assigned | — |
Medicinal ingredients
- MACITENTAN 10 MG per TAB