Skip to contentApplication 761328
- Type
- BLA
- Sponsor
- ASTRAZENECA AB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BEYFORTUS | NIRSEVIMAB-ALIP | INJECTABLE;INJECTION | 50MG | No | No |
| 002 | BEYFORTUS | NIRSEVIMAB-ALIP | INJECTABLE;INJECTION | 100MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85669 | SUPPL | 2026-04-10 |
| 85658 | SUPPL | 2026-04-09 |
| 83848 | SUPPL | 2025-10-21 |
| 83847 | SUPPL | 2025-10-21 |
| 79466 | SUPPL | 2024-08-26 |
| 79465 | SUPPL | 2024-08-23 |
| 77626 | SUPPL | 2024-02-26 |
| 77612 | SUPPL | 2024-02-26 |
| 75093 | ORIG | 2023-08-15 |
| 75092 | ORIG | 2023-07-18 |
| 75091 | ORIG | 2023-07-18 |