Approval · Notice of Compliance 7246 · 2005
PROLASTIN: Notice of Compliance 7246
Issued July 20, 2005
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
- 7246
- Date
- July 20, 2005
- Company
- Talecris Biotherapeutics, Inc.Clayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes in manufacturing facility
- Therapeutic class
- Alpha1-antitrypsin replenisher
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROLASTIN | Not yet assigned | — |
Medicinal ingredients
- ALPHA1-PROTEINASE INHIBITOR (HUMAN) 500 MG per VIAL
- ALPHA1-PROTEINASE INHIBITOR (HUMAN) 1 G per VIAL