Approval · Notice of Compliance 4807 · 1995
TRASYLOL: Notice of Compliance 4807
Issued December 28, 1995
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
- 4807
- Date
- December 28, 1995
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Two additional fill sizes - 100ml and 200ml, revisions to the method of manufacturing for all fill sizes
- Therapeutic class
- Hemostatic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRASYLOL | Not yet assigned | — |
Medicinal ingredients
- APROTININ 10,000 UNIT per ML