Approval · Notice of Compliance 20398 · 2018
PROLOPA: Notice of Compliance 20398
Issued January 23, 2018
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
- 20398
- Date
- January 23, 2018
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to product monograph, package inserts, inner and outer labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLOPA | Not yet assigned | — |
Medicinal ingredients
- BENSERAZIDE HCL 12.5 MG per CAP
- LEVODOPA 50 MG per CAP
- BENSERAZIDE HCL 25 MG per CAP
- LEVODOPA 100 MG per CAP
- BENSERAZIDE HCL 50 MG per CAP
- LEVODOPA 200 MG per CAP