Approval · Notice of Compliance 35687 · 2025
PROMETRIUM: Notice of Compliance 35687
Issued July 17, 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
- 35687
- Date
- July 17, 2025
- Company
- Organon Canada Inc.Kirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety information. Product Monograph reformatted to the Master Template. Update to Patient Medication Information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROMETRIUM | Not yet assigned | — |
Medicinal ingredients
- PROGESTERONE 100 MG per CAP