Approval · Notice of Compliance 21661 · 2018
ROPINIROLE: Notice of Compliance 21661
Issued December 20, 2018
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
- 21661
- Date
- December 20, 2018
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to product monograph and labels
- Canadian reference product
- REQUIP (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROPINIROLE | Not yet assigned | — |
Medicinal ingredients
- ROPINIROLE HYDROCHLORIDE 0.25 MG per TAB
- ROPINIROLE HYDROCHLORIDE 1 MG per TAB