Approval · Notice of Compliance 8249 · 2006
MIRAPEX: Notice of Compliance 8249
Issued September 8, 2006
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
- 8249
- Date
- September 8, 2006
- Company
- Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: symptomatic treatment of moderate to severe idiopathic restless legs syndrome
- Therapeutic class
- Antiparkinsonian agent / dopamine agonist
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MIRAPEX | Not yet assigned | — |
Medicinal ingredients
- PRAMIPEXOLE DIHYDROCHLORIDE 0.25 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE 0.5 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE 1 MG per TAB
- PRAMIPEXOLE DIHYDROCHLORIDE 1.5 MG per TAB