Application 761304
- Type
- BLA
- Sponsor
- ARGENX BV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VYVGART HYTRULO | EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC | INJECTABLE;INJECTION | 1008MG;11200UNITS PER 5.6ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85876 | SUPPL | 2026-05-11 |
| 85875 | SUPPL | 2026-05-11 |
| 85202 | SUPPL | 2026-03-02 |
| 85201 | SUPPL | 2026-03-02 |
| 83862 | SUPPL | 2025-10-21 |
| 83825 | SUPPL | 2025-10-20 |
| 81939 | SUPPL | 2025-04-21 |
| 81933 | SUPPL | 2025-04-21 |
| 79365 | SUPPL | 2024-08-12 |
| 79359 | SUPPL | 2024-08-09 |
| 78884 | SUPPL | 2024-06-24 |
| 78883 | SUPPL | 2024-06-24 |
| 78875 | SUPPL | 2024-06-24 |
| 78874 | SUPPL | 2024-06-24 |
| 77854 | ORIG | 2024-03-18 |
| 76784 | SUPPL | 2023-12-13 |
| 76780 | SUPPL | 2023-12-13 |
| 74582 | ORIG | 2023-06-21 |
| 74564 | ORIG | 2023-06-21 |