Approval · Notice of Compliance 9826 · 2008
GAMUNEX: Notice of Compliance 9826
Issued October 10, 2008
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
- 9826
- Date
- October 10, 2008
- Company
- Talecris Biotherapeutics, Inc.Clayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: chronic inflammatory demyelinating polyneuropathy
- Therapeutic class
- Passive immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GAMUNEX | Not yet assigned | — |
Medicinal ingredients
- IMMUNOGLOBULIN (HUMAN) 10 G per 100ML