U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Approval Year

2024
711
Name Type Language
fidanacogene elaparvovec [INN]
Preferred Name English
Fidanacogene Elaparvovec
INN  
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
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
Code System Code Type Description
INN
10798
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
DAILYMED
413EU9081Y
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
SMS_ID
100000177555
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
FDA UNII
413EU9081Y
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
NCI_THESAURUS
C171800
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
CAS
1954659-47-2
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
USAN
EF-63
Created by admin on Wed Apr 02 01:11:30 GMT 2025 , Edited by admin on Wed Apr 02 01:11:30 GMT 2025
PRIMARY
NIH
NCATS
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