Approval · Notice of Compliance 21141 · 2018
ADVATE: Notice of Compliance 21141
Issued July 26, 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
- 21141
- Date
- July 26, 2018
- Company
- Shire Pharma Canada UlcToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Merger - buyout
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ADVATE | 02365944 | Dormant |
| ADVATE | 02365952 | Dormant |
| ADVATE | 02284154 | Dormant |
| ADVATE | 02284162 | Dormant |
| ADVATE | 02313111 | Dormant |
| ADVATE | 02337193 | Dormant |
| ADVATE | 02365979 | Approved |
| ADVATE | 02365987 | Approved |
| ADVATE | 02446405 | Approved |
| ADVATE | 02446413 | Approved |
| ADVATE | 02446421 | Approved |
| ADVATE | 02446448 | Approved |
| ADVATE | 02446456 | Approved |
| ADVATE | 02446464 | Approved |
| ADVATE | 02446472 | Approved |
| ADVATE | 02446480 | Approved |
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
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 15,000 UNIT per VIAL