Approval · Notice of Compliance 11075 · 2010
PRAMIPEXOLE: Notice of Compliance 11075
Issued February 19, 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
- 11075
- Date
- February 19, 2010
- Company
- Cobalt Pharmaceuticals IncorporatedToronto, Ontario, 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 | 02344270 | Cancelled Pre Market |
| PRAMIPEXOLE | 02344289 | Cancelled Pre Market |
| PRAMIPEXOLE | 02344297 | Cancelled Pre Market |
| PRAMIPEXOLE | 02344300 | Cancelled Pre Market |
Medicinal ingredients
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG per TAB