Approval · Notice of Compliance 2977 · 1998
GAMIMUNE N: Notice of Compliance 2977
Issued September 21, 1998
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
- 2977
- Date
- September 21, 1998
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in manufacturing - alternate filtration separation step
- Therapeutic class
- Passive immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GAMIMUNE N | Not yet assigned | — |
Medicinal ingredients
- IMMUNOGLOBULIN (HUMAN) 5 MG per 100ML
- IMMUNOGLOBULIN (HUMAN) 10 MG per 100ML