Approval · Notice of Compliance 14043 · 2013
GAMUNEX: Notice of Compliance 14043
Issued January 29, 2013
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
- 14043
- Date
- January 29, 2013
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication for Guillain-Barre Syndrome (GBS)
- 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