Approval · Notice of Compliance 22981 · 2019
EVICEL: Notice of Compliance 22981
Issued December 5, 2019
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
- 22981
- Date
- December 5, 2019
- Company
- Omrix Biopharmaceuticals LtdNess Ziona, Israel
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of octapharma ag as an alternative cryoprecipitate supplier for the bac2 drug substance manufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EVICEL | Not yet assigned | — |
Medicinal ingredients
- THROMBIN (HUMAN) 1,200 UNIT per ML
- FIBRINOGEN (HUMAN) 90 MG per ML