FdaApplication
BLA 761107
Identifiers
- fda_app_no: BLA761107
Properties
| Property | Value |
|---|---|
| applicant_name | Swedish Orphan Biovitrum AB (publ) |
| application_type | BLA |
| approval_date | 2018-11-20 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GAMIFANT | EMAPALUMAB-LZSG | 50MG/10ML (5MG/ML) | Injection |
| GAMIFANT | EMAPALUMAB-LZSG | 10MG/2ML (5MG/ML) | Injection |
| GAMIFANT | EMAPALUMAB-LZSG | 100MG/20ML (5MG/ML) | Injection |
| GAMIFANT | — | 250MG/10ML (25MG/ML) | Injection |
| GAMIFANT | — | 50MG/2ML (25MG/ML) | Injection |
| GAMIFANT | — | 100MG/4ML (25MG/ML) | Injection |
6 products