Approval · Notice of Compliance 30774 · 2023
FULPHILA: Notice of Compliance 30774
Issued May 15, 2023
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
- 30774
- Date
- May 15, 2023
- Company
- Biosimilar Collaborations Ireland LimitedDublin, Ireland
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Administrative - Change in Product Ownership
- Canadian reference product
- NEULASTA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FULPHILA | 02484153 | Marketed |
Medicinal ingredients
- PEGFILGRASTIM 10 MG per ML