Approval · Notice of Compliance 22074 · 2019
KEYTRUDA: Notice of Compliance 22074
Issued April 18, 2019
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 22074
- Date
- April 18, 2019
- 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 is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic microsate life instability-high (msi-h) or mismatch repair deficient (dmmr) colorectawl cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan or endometrial cancer that has progressed following prior therapy andn who have no satisfactory alternative treatment oiptions
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | Not yet assigned | — |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL
- PEMBROLIZUMAB 25 MG per ML