Approval · Notice of Compliance 12179 · 2011
ADVATE: Notice of Compliance 12179
Issued March 18, 2011
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
- 12179
- Date
- March 18, 2011
- Company
- Baxter Healthcare CorporationDeerfield, Illinois, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Reconstitution in 2ml sterile water
- Therapeutic class
- Coagulant
Products in this notice
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3,000 UNIT per VIAL