DIRLOCTOCOGENE SAMOPARVOVEC

Approval Year

Substance Class	Structurally Diverse Created by `admin` on `Wed Apr 02 00:44:58 GMT 2025` Edited by `admin` on `Wed Apr 02 00:44:58 GMT 2025`
Source Materials Class	ORGANISM
Source Materials Type	RECOMBINANT VIRUS
Source Materials State	LIVE NON-REPLICATING GENETICALLY MODIFIED
Organism Family	Parvoviridae
Organism Genus	Dependovirus
Organism Species	adeno-associated virus
Author	NONE
Infraspecific Type	SUBSTRAIN
Infraspecific Name	AAV2(ITR)/AAV1, 2, 3B, 4, 5, 6 8, 9, AVIAN AND BOVINE AAV(PALSMID) FOLLOWED BY IN VIVOSELECTION IN FAH//RAG2//IL2RG/ (FRG) MICE PARTIALLY REPOPULATED WITH HUMAN HEPATOCYTES/HUMAN B-DOMAIN-DELETED BLOOD COAGULATION FACTOR VIII (HF8, FVIII)/TTRM/VECTOR
Part	whole
Record UNII	I2G2SZ8B0C
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

dirloctocogene samoparvovec [INN]

Preferred Name

English

DIRLOCTOCOGENE SAMOPARVOVEC

Official Name

English

SPK-8011

Code

English

DIRLOCTOCOGENE SAMOPARVOVEC [USAN]

Common Name

English

SPK8011

Code

English

AAV-SPARK 200-HFVIII

Common Name

English

DNA (RECOMBINANT ADENO-ASSOCIATED VIRUS 2 VECTOR AAVSPK200HFVIII8011 HUMAN B-DOMAIN-DELETED BLOOD-COAGULATION FACTOR VIII-SPECIFYING)

Common Name

English

A RECOMBINANT NON-REPLICATING ADENO-ASSOCIATED VIRUS VECTOR WITH A BIO-ENGINEERED CAPSID DERIVED BY DNA SHUFFLING OF 10 AAV CAPSID SEQUENCES (AAV1, 2, 3B, 4, 5, 6 8, 9, AVIAN AND BOVINE AAV) FOLLOWED BY IN VIVOSELECTION IN FAH//RAG2//IL2RG/ (FRG) MICE PA

Common Name

English

Dirloctocogene samoparvovec [WHO-DD]

Common Name

English

Code System Code Type Description

FDA UNII

I2G2SZ8B0C