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 |