Approval · Notice of Compliance 28074 · 2022
IPG-SERTRALINE: Notice of Compliance 28074
Issued May 3, 2022
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
- 28074
- Date
- May 3, 2022
- Company
- Marcan Pharmaceuticals Inc.Ottawa, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Safety updates to the product monograph. Update to labels to align with plain language labelling regulations
- Canadian reference product
- ZOLOFT (Pfizer Canada Ulc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| IPG-SERTRALINE | Not yet assigned | — |
Medicinal ingredients
- SERTRALINE HYDROCHLORIDE 25 MG per CAP
- SERTRALINE HYDROCHLORIDE 50 MG per CAP
- SERTRALINE HYDROCHLORIDE 100 MG per CAP