Application 761107

Type: BLA
Sponsor: NOVIMMUNE S.A.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761107	Gamifant	emapalumab-lzsg	351(a)	Rx	2026-07-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GAMIFANT	EMAPALUMAB-LZSG	INJECTABLE;INJECTION	10MG/2ML	No	No
002	GAMIFANT	EMAPALUMAB-LZSG	INJECTABLE;INJECTION	50MG/10ML	No	No
003	GAMIFANT	EMAPALUMAB-LZSG	INJECTABLE;INJECTION	100MG/20ML	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAMIFANT	EMAPALUMAB-LZSG	Swedish Orphan Biovitrum AB (publ)	a865e0ef-8685-4f69-8838-648c4f3bab47	2026-03-26	Warnings, Adverse reactions	Exact identifier application number: BLA761107 ndc (product): 66658-510 ndc (product): 66658-505 ndc (product): 66658-501

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66658-501	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-501	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-501	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-505	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-505	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-505	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-510	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
66658-510	GAMIFANT	(emapalumab-lzsg)	Swedish Orphan Biovitrum AB (publ)	BLA	Current
72171-501	GAMIFANT	(emapalumab-lzsg)	NovImmune SA	BLA	Current
72171-501	GAMIFANT	(emapalumab-lzsg)	NovImmune SA	BLA	Current
72171-505	GAMIFANT	(emapalumab-lzsg)	NovImmune SA	BLA	Current
72171-505	GAMIFANT	(emapalumab-lzsg)	NovImmune SA	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85507	SUPPL	2026-03-24
85474	SUPPL	2026-03-24
85398	SUPPL	2026-03-19
82714	SUPPL	2025-06-30
82695	SUPPL	2025-06-30
56754	ORIG	2018-12-17
56532	ORIG	2018-11-21
56516	ORIG	2018-11-20