Approval · Notice of Compliance 22368 · 2019
FLUOXETINE: Notice of Compliance 22368
Issued July 5, 2019
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
- 22368
- Date
- July 5, 2019
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Revisions to labels. labelling update to match licensor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FLUOXETINE | Not yet assigned | — |
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 10 MG per CAP
- FLUOXETINE HYDROCHLORIDE 20 MG per CAP