Approval · Notice of Compliance 10682 · 2009
PRAMIPEXOLE: Notice of Compliance 10682
Issued October 16, 2009
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
- 10682
- Date
- October 16, 2009
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Additional product name
- Therapeutic class
- Antiparkinsonian agent / Dopamine agonist
- Canadian reference product
- MIRAPEX (Boehringer Ingelheim (Canada) Ltd.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRAMIPEXOLE | 02334607 | — |
| PRAMIPEXOLE | 02334615 | — |
| PRAMIPEXOLE | 02334623 | — |
Medicinal ingredients
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG per TAB