Approval · Notice of Compliance 19338 · 2017
PROHANCE: Notice of Compliance 19338
Issued May 19, 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
- 19338
- Date
- May 19, 2017
- Company
- Bracco Imaging CanadaVille D'Anjou, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To improve the safety information in the product monograph for prohance in response to health canada's class labelling request issued on february 14, 2017 for all gdolinium based contrast agents (gbcas) product with refgard to gadolinium (gd) accumulation in the brain
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROHANCE | Not yet assigned | — |
Medicinal ingredients
- GADOTERIDOL 279.3 MG per ML