Approval · Notice of Compliance 20886 · 2018
KEYTRUDA: Notice of Compliance 20886
Issued May 23, 2018
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
- 20886
- Date
- May 23, 2018
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Fulfullment of commitment 2c of the letter of undertaking dated april 1, 2016 issued under sans control # 186275
- 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