Approval · Notice of Compliance 30562 · 2023
KEYTRUDA: Notice of Compliance 30562
Issued April 19, 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
- 30562
- Date
- April 19, 2023
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Keytruda as monotherapy is indicated for the adjuvant treatment of adult patients with Stage IB (T2a >/- 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 25 MG per ML