Approval · Notice of Compliance 20175 · 2017
HEPAGAM B: Notice of Compliance 20175
Issued December 20, 2017
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 20175
- Date
- December 20, 2017
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Transfer of drug identification number (din)
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HEPAGAM B | Not yet assigned | — |
Medicinal ingredients
- HEPATITIS B IMMUNOGLOBULIN (HUMAN) 312 UNIT per ML