Application 761428
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALHEMO | CONCIZUMAB | SOLUTION; INJECTION | 60MG/1.5ML (40MG/ML) | No | No |
| 002 | ALHEMO | CONCIZUMAB | SOLUTION; INJECTION | 150MG/1.5ML (100MG/ML) | No | No |
| 003 | ALHEMO | CONCIZUMAB | SOLUTION; INJECTION | 300MG/3ML (100MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alhemo | CONCIZUMAB | Novo Nordisk | 156f6404-1f6f-417f-bcf8-f07a27a82cc1 | 2025-07-01 | Warnings, Adverse reactions | Alhemo CONCIZUMAB |