Approval · Notice of Compliance 18471 · 2016
ADENOSINE INJECTION: Notice of Compliance 18471
Issued September 9, 2016
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
- 18471
- Date
- September 9, 2016
- Company
- Fresenius Kabi Canada LtdToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Addition of alternate api manufacturing site (farmak, as) alternate drug product manufacturing site (fresenius kabi austria gmbh in graz)( and alternative packaging format for adenosine injection in pfs (6 mg/2ml and 12 mg/4 ml in 5 ml pre-filled syringe)
- Canadian reference product
- ADENOCARD (Astellas Pharma Canada Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADENOSINE INJECTION | Not yet assigned | — |
Medicinal ingredients
- ADENOSINE 3 MG per ML