Approval · Notice of Compliance 19181 · 2017
ZOMETA: Notice of Compliance 19181
Issued April 19, 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
- 19181
- Date
- April 19, 2017
- Company
- Novartis Pharmaceuticals Canada Inc.Montreal, 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 safety information on osteonecrosis of the jaw in response to an advisement letter
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZOMETA | 02248296 | Marketed |
Medicinal ingredients
- ZOLEDRONIC ACID 4 MG per 5ML