Approval · Notice of Compliance 31205 · 2023
LYSODREN: Notice of Compliance 31205
Issued July 13, 2023
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
- 31205
- Date
- July 13, 2023
- Company
- Hra Pharma Rare Diseases
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Active Substance Master File. Changes to specifications for the active pharmaceutical ingredient (API). Changes to the analytical procedures to characterize the API. To extend the retest period of the API to 3 years.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LYSODREN | Not yet assigned | — |
Medicinal ingredients
- MITOTANE 500 MG per TAB