Approval · Notice of Compliance 16911 · 2015
KEYTRUDA: Notice of Compliance 16911
Issued May 19, 2015
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
- 16911
- Date
- May 19, 2015
- Company
- Merck Canada IncKirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Antinmeoplastic agent
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KEYTRUDA | 02441152 | Cancelled Post Market |
Medicinal ingredients
- PEMBROLIZUMAB 50 MG per VIAL