Approval · Notice of Compliance 19242 · 2017
MULTIHANCE: Notice of Compliance 19242
Issued April 3, 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
- 19242
- Date
- April 3, 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 support the addition of an indication for the use in breast mri for the detection of malignant lesionsin patients where breast cancer is known or suspected on the basis of previous mammography or ultrasound results
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MULTIHANCE | Not yet assigned | — |
Medicinal ingredients
- GADOBENATE DIMEGLUMINE 529 MG per ML