Approval · Notice of Compliance 30207 · 2023
URSO: Notice of Compliance 30207
Issued February 23, 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
- 30207
- Date
- February 23, 2023
- Company
- Aptalis Pharma Canada UlcMarkham, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To update the Product Monograph (PM) with new safety information about enterolithiasis and to convert the PM to the Master Template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| URSO | Not yet assigned | — |
| URSO DS | Not yet assigned | — |