Active ingredient
Emapalumab
7 finished FDA listings contain Emapalumab as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- EMAPALUMAB
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 1
- Strengths listed
- 10 mg/2ml · 100 mg/20ml · 100 mg/4ml · 250 mg/10ml · 50 mg/10ml · 50 mg/2ml · 500 mg/20ml
- Brand names in FDA listings
- Gamifant
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2104604
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 761107 | NOVIMMUNE S.A. | 2018-11-20 | 7 |
Official labeling on DailyMed
- GAMIFANT (EMAPALUMAB-LZSG) INJECTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] · version 10 · 2026-03-31
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.