Approval · Notice of Compliance 23834 · 2020
PROLOPA: Notice of Compliance 23834
Issued June 24, 2020
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
- 23834
- Date
- June 24, 2020
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of intermediate manufacturing site, Addition of starting material manufacturing site, Change in batch size of intermediate.
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