Approval · Notice of Compliance 10867 · 2009
RECOTHROM: Notice of Compliance 10867
Issued December 15, 2009
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
- 10867
- Date
- December 15, 2009
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
- Therapeutic class
- Coagulation factor
Products in this notice
Medicinal ingredients
- THROMBIN ALFA 24,000 UNIT per VIAL
- THROMBIN ALFA 6,000 UNIT per VIAL