Approval · Notice of Compliance 31675 · 2023
PREVYMIS: Notice of Compliance 31675
Issued September 21, 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
- 31675
- Date
- September 21, 2023
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication in the prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients who are at high risk. Product Monograph update to the master template
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PREVYMIS | Not yet assigned | — |
Medicinal ingredients
- LETERMOVIR 240 MG per TAB
- LETERMOVIR 480 MG per TAB
- LETERMOVIR 480 MG per 24ML
- LETERMOVIR 240 MG per 12ML