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Drug ReportsMoroctocog alfa
Moroctocog alfa
ReFacto (moroctocog alfa) is a protein pharmaceutical. Moroctocog alfa was first approved as Refacto af on 1999-04-13. It has been approved in Europe to treat hemophilia a.
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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
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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
xynthaBiologic Licensing Application2011-01-13
Indications
FDA
EMA
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Agency Specific
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
379 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_0007267D662186724
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia bD002836—D67——5—27
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMoroctocog alfa
INNmoroctocog alfa
Description
Moroctocog alfa (trade name ReFacto in the EU) is a recombinant antihemophilic factor genetically engineered from Chinese hamster ovary (CHO) cell line. Chemically it is a glycoprotein. It is manufactured by Genetics Institute, Inc. and used to control and prevent hemorrhagic bleeding and prophylaxis associated with surgery or to reduce the number of spontaneous bleeding episodes in patients with hemophilia A. It is partially a recombinant coagulation factor VIII since it has an amino acid sequence which compares to the 90 + 80 kDa form of factor VIII (BDDrFVIII). It also has posttranslational modifications which are similar to those of the plasma-derived molecule. It can not prevent hemorrhagic bleeding associated with von Willebrand's disease since it is not a von Willebrand factor.
Classification
Protein
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2109137
ChEBI ID—
PubChem CID—
DrugBankDB13999
UNII ID113E3Z3CJJ (ChemIDplus, GSRS)
Target
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Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Refacto – Pfizer
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 380 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,917 adverse events reported
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