Approval · Notice of Compliance 19117 · 2017
BONEFOS: Notice of Compliance 19117
Issued March 31, 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
- 19117
- Date
- March 31, 2017
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the warnings & precautions section of the product monograph regarding osteonecrosis of the jaw (onj) warnings in response to an advisement letter
Products in this notice
Medicinal ingredients
- CLODRONATE DISODIUM 60 MG per ML
- CLODRONATE DISODIUM 400 MG per MG