GAMIFANT is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Swedish Orphan Biovitrum Ab (publ). The primary component is Emapalumab.
| Product ID | 66658-510_5a77518a-477d-47fa-a0d4-ce986eb7e964 |
| NDC | 66658-510 |
| Product Type | Human Prescription Drug |
| Proprietary Name | GAMIFANT |
| Generic Name | (emapalumab-lzsg) |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-06-26 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761107 |
| Labeler Name | Swedish Orphan Biovitrum AB (publ) |
| Substance Name | EMAPALUMAB |
| Active Ingredient Strength | 100 mg/20mL |
| Pharm Classes | Interferon gamma Blocker [EPC],Interferon gamma Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-06-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 66658-501 | GAMIFANT | (emapalumab-lzsg) |
| 66658-505 | GAMIFANT | (emapalumab-lzsg) |
| 66658-510 | GAMIFANT | (emapalumab-lzsg) |
| 72171-501 | GAMIFANT | (emapalumab-lzsg) |
| 72171-505 | GAMIFANT | (emapalumab-lzsg) |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GAMIFANT 87283834 5505933 Live/Registered |
EMACO SA 2016-12-29 |