Approval · Notice of Compliance 10047 · 2009
NPLATE: Notice of Compliance 10047
Issued February 19, 2009
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
- 10047
- Date
- February 19, 2009
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
- Therapeutic class
- Thrombopoiesis-stimulating protein
Products in this notice
Medicinal ingredients
- ROMIPLOSTIM 500 MCG per ML
- ROMIPLOSTIM 250 MCG per 0.5ML