Approval · Notice of Compliance 26654 · 2021
HYPERTET: Notice of Compliance 26654
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
- 26654
- 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, change in the description of the drug product and removal of a primary container
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HYPERTET | 02520087 | Marketed |
Medicinal ingredients
- TETANUS IMMUNOGLOBULIN (HUMAN) 250 UNIT per 1ML