Approval · Notice of Compliance 12327 · 2011
DIGIFAB: Notice of Compliance 12327
Issued May 9, 2011
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
- 12327
- Date
- May 9, 2011
- Company
- Btg International IncWest Conshohocken, Pennsylvania, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Specific antibody for digoxin
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DIGIFAB | 02361043 | Marketed |
Medicinal ingredients
- DIGOXIN IMMUNE FAB (OVINE) 40 MG per VIAL