Approval · Notice of Compliance 26653 · 2021
HYPERHEP B: Notice of Compliance 26653
Issued September 8, 2021
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
- 26653
- Date
- September 8, 2021
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the manufacturing process, to the description of the drug product and new presentation
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYPERHEP B | 02520001 | Marketed |
| HYPERHEP B | 02520125 | Marketed |
| HYPERHEP B | 02520133 | Approved |
Medicinal ingredients
- HEPATITIS B IMMUNOGLOBULIN (HUMAN) 220 UNIT per 1ML
- HEPATITIS B IMMUNOGLOBULIN (HUMAN) 220 UNIT per VIAL
- HEPATITIS B IMMUNOGLOBULIN (HUMAN) 220 UNIT per SYR