Approval · Notice of Compliance 10631 · 2009
ACLASTA: Notice of Compliance 10631
Issued October 4, 2009
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
- 10631
- Date
- October 4, 2009
- 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
- New indication: The prevention of postmenopausal osteoporosis in women with osteopenia as a single intravenous infusion
- Therapeutic class
- Bone metabolism regulator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ACLASTA | Not yet assigned | — |
Medicinal ingredients
- ZOLEDRONIC ACID 5 MG per 100ML