Approval · Notice of Compliance 19153 · 2017
ACLASTA: Notice of Compliance 19153
Issued April 11, 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
- 19153
- Date
- April 11, 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 regarding osteonecrosis of the jaw (onj) in response to an advisement letter
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACLASTA | 02269198 | Marketed |
Medicinal ingredients
- ZOLEDRONIC ACID 5 MG per 100ML