Approval · Notice of Compliance 35317 · 2025
OCALIVA: Notice of Compliance 35317
Issued May 7, 2025
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
- 35317
- Date
- May 7, 2025
- Company
- Advanz Pharma Canada Inc.Mississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the starting material. Change in the manufacturing process for the starting material. Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Change in the manufacturing process for the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OCALIVA | Not yet assigned | — |
Medicinal ingredients
- OBETICHOLIC ACID 5 MG per TAB
- OBETICHOLIC ACID 10 MG per TAB