Approval · Notice of Compliance 34010 · 2024
IMDELLTRA: Notice of Compliance 34010
Issued September 11, 2024
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
- 34010
- Date
- September 11, 2024
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- With conditions
- Yes (NOC/c)
Products in this notice
Medicinal ingredients
- TARLATAMAB 1 MG per VIAL
- TARLATAMAB 10 MG per VIAL