Approval · Notice of Compliance 24413 · 2020
ZERBAXA: Notice of Compliance 24413
Issued October 9, 2020
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
- 24413
- Date
- October 9, 2020
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add standard safety warnings to the Product Monograph regarding beta-lactam antibiotics and risk of severe skin side effects (Severe Cutaneous Adverse Reactions, SCAR).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ZERBAXA | Not yet assigned | — |
Medicinal ingredients
- TAZOBACTAM SODIUM 0.5 G per VIAL
- CEFTOLOZANE SULFATE 1 G per VIAL