Approval · Notice of Compliance 20648 · 2018
RECOTHROM: Notice of Compliance 20648
Issued March 6, 2018
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
- 20648
- Date
- March 6, 2018
- Company
- Mallinckrodt Hospital Products IncBridgewater, New Jersey, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Labelling Only
- Reason
- Transfer of Drug Identification Numbers (DINs) and labelling updates
Products in this notice
Medicinal ingredients
- THROMBIN ALFA 6,000 UNIT per VIAL
- THROMBIN ALFA 24,000 UNIT per VIAL