Approval · Notice of Compliance 16733 · 2015
GAMUNEX: Notice of Compliance 16733
Issued March 30, 2015
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
- 16733
- Date
- March 30, 2015
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New manufacturing site
- 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