Approval · Notice of Compliance 11535 · 2010
ROPINIROLE: Notice of Compliance 11535
Issued June 18, 2010
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
- 11535
- Date
- June 18, 2010
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antiparkinsonian agent / Dopamine agonist
- Canadian reference product
- REQUIP (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ROPINIROLE | 02353040 | Cancelled Post Market |
| ROPINIROLE | 02353059 | Cancelled Post Market |
| ROPINIROLE | 02353067 | Cancelled Post Market |
| ROPINIROLE | 02353075 | Cancelled Post Market |
Medicinal ingredients
- ROPINIROLE HYDROCHLORIDE 0.25 MG per TAB
- ROPINIROLE HYDROCHLORIDE 1 MG per TAB
- ROPINIROLE HYDROCHLORIDE 2 MG per TAB
- ROPINIROLE HYDROCHLORIDE 5 MG per TAB