Skip to contentApplication 761315
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Application Products#
Product, Drug, Ingredient table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83030 | SUPPL | 2025-08-01 |
| 83029 | SUPPL | 2025-08-01 |
| 83021 | SUPPL | 2025-08-01 |
| 82261 | SUPPL | 2025-05-02 |
| 80919 | ORIG | 2025-02-05 |
| 80745 | ORIG | 2024-12-27 |
| 80676 | ORIG | 2024-12-20 |