Approval · Notice of Compliance 14724 · 2013
BERINERT: Notice of Compliance 14724
Issued September 11, 2013
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
- 14724
- Date
- September 11, 2013
- Company
- Csl Behring Canada IncOttawa, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of indication: for the treatment of acute abdominal facial or laryngeal attacks of hereditory angiodema (hae) of moderate to severe intensity
- Therapeutic class
- Human c1 esterase inhibitor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BERINERT | Not yet assigned | — |
Medicinal ingredients
- C1 ESTERASE INHIBITOR (HUMAN) 625 UNIT per 10ML