Approval · Notice of Compliance 12992 · 2012
HYPERRHO S/D FULL DOSE: Notice of Compliance 12992
Issued February 2, 2012
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
- 12992
- Date
- February 2, 2012
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Passive Immunizing Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYPERRHO S/D FULL DOSE | 02243524 | Cancelled Pre Market |
| HYPERRHO S/D FULL DOSE | 02379457 | Approved |
Medicinal ingredients
- ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1,500 UNIT per DOSE
- ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1,500 UNIT per SYR