Approval · Notice of Compliance 19357 · 2017
FOSAMAX: Notice of Compliance 19357
Issued May 30, 2017
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
- 19357
- Date
- May 30, 2017
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the warnings and precautions section of the product monograph in response to an advisement letter to strengthen labelling regarding osteonecrosis of the jaw (onj)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FOSAMAX | Not yet assigned | — |
Medicinal ingredients
- ALENDRONATE SODIUM 70 MG per MG