Approval · Notice of Compliance 22848 · 2019
MULTIHANCE: Notice of Compliance 22848
Issued November 1, 2019
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
- 22848
- Date
- November 1, 2019
- 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 expand the posology of multihance to include a lower floor of 0.05 mmol/kg (0.1 ml/kg) as the lowest effective dose in patients undergoing mri of the cns, in particular in patients with known or suspected extra-axial cns lesions and/or when 3.0t mr scanners are used to perform the multihance enhanced mri examination
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MULTIHANCE | Not yet assigned | — |
Medicinal ingredients
- GADOBENATE DIMEGLUMINE 529 MG per ML