Approval · Notice of Compliance 21823 · 2019
ROCALTROL: Notice of Compliance 21823
Issued February 4, 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
- 21823
- Date
- February 4, 2019
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Update to the Package Insert and outer labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROCALTROL | Not yet assigned | — |
Medicinal ingredients
- CALCITRIOL 0.25 MCG per CAP
- CALCITRIOL 0.5 MCG per CAP