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Drug ReportsNonacog alfa
Nonacog alfa
BeneFIX (nonacog alfa) is a protein pharmaceutical. Nonacog alfa was first approved as Benefix on 1997-08-27. It is used to treat factor VII deficiency, hemophilia a, hemophilia b, and hypoprothrombinemias in the USA. It has been approved in Europe to treat hemophilia b.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
benefixBiologic Licensing Application2010-12-16
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
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HCPCS
No data
Clinical
Clinical Trials
163 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia aD006467EFO_0007267D663225451447146
Hemophilia bD002836—D672926421141131
Blood coagulation disordersD001778EFO_0009314D68.91—3217
Hemostatic disordersD020141——1—3217
HemorrhageD006470MP_0001914R58——23—5
Cardiac surgical proceduresD006348—————2—2
Joint diseasesD007592HP_0003040M12.9———112
Hiv infectionsD015658EFO_0000764B20———1—1
OsteoarthritisD010003EFO_0002506M15-M19———1—1
HemarthrosisD006395EFO_1001344M25.0———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombocytopeniaD013921HP_0001873D69.6——1——1
Hematologic diseasesD006402EFO_0005803D75.9——1——1
Hemorrhagic disordersD006474—D69.9——1——1
Hemorrhagic shockD012771————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombosisD013927——11———2
Venous thromboembolismD054556EFO_0004286I74—1———1
EmbolismD004617———1———1
ThromboembolismD013923HP_0001907——1———1
Embolism and thrombosisD016769———1———1
Hip fracturesD006620EFO_0003964S72.00—1———1
Bone fracturesD050723EFO_0003931T14.8—1———1
TranssexualismD014189—F64.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MenorrhagiaD008595EFO_0003945N92.01————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypersensitivityD006967HP_0012393T78.40————22
MucopolysaccharidosesD009083—E76.3————11
Mucopolysaccharidosis iD008059—E76.0————11
Mucopolysaccharidosis iiD016532—E76.1————11
Liver transplantationD016031EFO_0010682—————11
Von willebrand diseasesD014842EFO_0003910D68.0————11
HemostasisD006487——————11
Genetic therapyD015316——————11
OsteoporosisD010024HP_0000939M81.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNonacog alfa
INNnonacog alfa
Description
BeneFIX (nonacog alfa) is a protein pharmaceutical. Nonacog alfa was first approved as Benefix on 1997-08-27. It is used to treat factor vii deficiency, hemophilia a, hemophilia b, and hypoprothrombinemias in the USA. It has been approved in Europe to treat hemophilia b.
Classification
Protein
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2109205
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID382L14738L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Benefix – Pfizer
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 287 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,767 adverse events reported
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