Approval · Notice of Compliance 29958 · 2023
EDURANT: Notice of Compliance 29958
Issued January 20, 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
- 29958
- Date
- January 20, 2023
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Removal of the term ¿considered as ADRs¿ for abnormal laboratory findings presented in the Adverse Reactions section of the Product Monograph (PM); PM reformatted to the Master Template; Removal of package insert from packaging
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EDURANT | Not yet assigned | — |
Medicinal ingredients
- RILPIVIRINE HYDROCHLORIDE 25 MG per TAB