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Cerezyme(imiglucerase)
Cerezyme (imiglucerase) is an enzyme pharmaceutical. Imiglucerase was first approved as Cerezyme on 1994-05-23. It is used to treat gaucher disease, liver diseases, and splenic diseases in the USA. It has been approved in Europe to treat gaucher disease.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
nervous system diseasesD009422
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Cerezyme
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)
Imiglucerase
Tradename
Proper name
Company
Number
Date
Products
CerezymeimigluceraseGenzyme CorporationN-20367 RX1999-09-22
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cerezymeBiologic Licensing Application2021-04-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gaucher diseaseOrphanet_355D005776E75.22
liver diseasesEFO_0001421D008107K70-K77
splenic diseasesEFO_0009002D013158D73
Agency Specific
FDA
EMA
Expiration
Code
imiglucerase, Cerezyme, Genzyme Corporation
2101-05-23Orphan 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
— A16AB02: Imiglucerase
HCPCS
Code
Description
J1786
Injection, imiglucerase, 10 units
S9357
Home infusion therapy, enzyme replacement intravenous therapy; (e.g., imiglucerase); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gaucher diseaseD005776Orphanet_355E75.225473221
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G20————11
DementiaD003704F03————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIMIGLUCERASE
INNimiglucerase
Description
Cerezyme (imiglucerase) is an enzyme pharmaceutical. Imiglucerase was first approved as Cerezyme on 1994-05-23. It is used to treat gaucher disease, liver diseases, and splenic diseases in the USA. It has been approved in Europe to treat gaucher disease.
Classification
Enzyme
Drug classenzymes
Image (chem structure or protein)IMIGLUCERASE
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB1OGS, 1Y7V, 2F61, 2J25, 2NSX, 2NT0, 2NT1, 2V3D, 2V3E, 2V3F, 2WKL, 2XWD, 2XWE, 3GXD, 3GXF, 3GXI, 3GXM, 3KE0, 3KEH, 3RIK, 3RIL, 5LVX, 6MOZ, 6Q6K, 6Q6L, 6Q6N, 6TJJ, 6TJK, 6TJQ, 6TN1, 6YTP, 6YTR, 6YUT, 6YV3, 6Z39, 6Z3I, 7NWV
CAS-ID154248-97-2
RxCUI84959
ChEMBL IDCHEMBL1201632
ChEBI ID—
PubChem CID—
DrugBankDB00053
UNII IDQ6U6J48BWY (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Cerezyme - Sanofi
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 875 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,545 adverse events reported
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