Approval · Notice of Compliance 27044 · 2021
PRAMIPEXOLE: Notice of Compliance 27044
Issued November 14, 2021
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
- 27044
- Date
- November 14, 2021
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- Administrative: Labelling Update (to Match Licensor)
- Canadian reference product
- MIRAPEX (Boehringer Ingelheim (Canada) Ltd.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRAMIPEXOLE | Not yet assigned | — |
Medicinal ingredients
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG per TAB