Approval · Notice of Compliance 12990 · 2012
GAMUNEX: Notice of Compliance 12990
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
- 12990
- 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 Immunizint Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GAMUNEX | 02247724 | Marketed |
Medicinal ingredients
- IMMUNOGLOBULIN (HUMAN) 10 G per 100ML