Fidanacogene Elaparvovec

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 01:11:30 GMT 2025` Edited by `admin` on `Wed Apr 02 01:11:30 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	RECOMBINANT VIRUS
Source Materials State	LIVE NON-REPLICATING GENETICALLY MODIFIED
Organism Family	Parvoviridae
Organism Genus	Dependoparvovirus
Organism Species	adeno-associated dependoparvovirus a
Infraspecific Type	RECOMBINANT VECTOR
Infraspecific Name	NON-REPLICATING ADENO-ASSOCIATED VIRUS SEROTYPE 2 (AAV2) EXPRESSING THE PADUA VARIANT (R338L) OF HUMAN COAGULATION FACTOR IX
Part	whole
Record UNII	413EU9081Y
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

fidanacogene elaparvovec [INN]

Preferred Name

English

Fidanacogene Elaparvovec

Official Name

English

SPK-9001

Code

English

PF-06838435

Common Name

English

SPK-1001

Code

English

FIDANACOGENE ELAPARVOVEC [USAN]

Common Name

English

SPK-FIX PADUA

Common Name

English

A NON-REPLICATING ADENO-ASSOCIATED VIRUS SEROTYPE 2 (AAV2) EXPRESSING THE PADUA VARIANT (R338L) OF HUMAN COAGULATION FACTOR IX (F9, FACTOR IX, FIX), UNDER THE CONTROL OF THE LIVER-SPECIFIC APOLIPOPROTEIN E (APO E) ENHANCER/ALPHA1-ANTITRYPSIN (HAAT) PROMO

Common Name

English

SPARK 101

Common Name

English

DNA (SYNTHETIC ADENO-ASSOCIATED VIRUS VECTOR AAV-SPARK100-HFIX39-PADUA)

Systematic Name

English

RAAV-SPARK100-HFIX-PADUA

Common Name

English

AAV8 HFIX19

Common Name

English

Fidanacogene elaparvovec [WHO-DD]

Common Name

English

Classification Tree Code System Code

EU-Orphan Drug

EU/3/18/2090