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Naglazyme , Naglazyme(galsulfase)
Naglazyme (galsulfase) is an enzyme pharmaceutical. Galsulfase was first approved as Naglazyme on 2005-05-31. It is used to treat mucopolysaccharidosis VI in the USA. It has been approved in Europe to treat mucopolysaccharidosis VI.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Naglazyme
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Galsulfase
Tradename
Proper name
Company
Number
Date
Products
Naglazyme galsulfase BioMarin PharmaceuticalN-125117 RX2005-05-31
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
naglazymeBiologic Licensing Application2020-04-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
mucopolysaccharidosis vi—D009087—
Agency Specific
FDA
EMA
Expiration
Code
galsulfase , Naglazyme , BioMarin Pharmaceutical Inc.
2112-05-31Orphan excl.
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB08: Galsulfase
HCPCS
Code
Description
J1458
Injection, galsulfase, 1 mg
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mucopolysaccharidosis viD009087112116
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGALSULFASE
INNgalsulfase
Description
Naglazyme (galsulfase) is an enzyme pharmaceutical. Galsulfase was first approved as Naglazyme on 2006-01-23. It is used to treat mucopolysaccharidosis vi in the USA. It has been approved in Europe to treat mucopolysaccharidosis vi.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201822
ChEBI ID—
PubChem CID—
DrugBankDB01279
UNII ID59UA429E5G (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Naglazyme - BioMarin Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 266 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,784 adverse events reported
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