Application 761315
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761315 | Alhemo | concizumab-mtci | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALHEMO | CONCIZUMAB-MTCI | Injectable; Subcutaneous | 60MG/1.5ML(40MG/ML) | No | No |
| 002 | ALHEMO | CONCIZUMAB-MTCI | Injectable; Subcutaneous | 150MG/1.5ML(100MG/ML) | No | No |
| 003 | ALHEMO | CONCIZUMAB-MTCI | Injectable; Subcutaneous | 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 | BLA761315 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.