Approval · Notice of Compliance 13291 · 2012
PRAMIPEXOLE: Notice of Compliance 13291
Issued May 25, 2012
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
- 13291
- Date
- May 25, 2012
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Antiparkinsonian Agent; Dopaimine Agonist
- Canadian reference product
- MIRAPEX (Boehringer Ingelheim (Canada) Ltd.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRAMIPEXOLE | 02309122 | Marketed |
| PRAMIPEXOLE | 02309130 | Marketed |
| PRAMIPEXOLE | 02309149 | Marketed |
| PRAMIPEXOLE | 02309157 | Marketed |
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