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Retavase, Rapilysin(reteplase)
Rapilysin, Retavase (reteplase) is an enzyme pharmaceutical. Reteplase was first approved as Rapilysin on 1996-08-29. It is used to treat myocardial infarction and ventricular dysfunction in the USA. It has been approved in Europe to treat myocardial infarction.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Retavase
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)
Reteplase
Tradename
Proper name
Company
Number
Date
Products
RetavasereteplaseChiesi USA, Inc.N-103786 RX1996-10-30
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
retavaseBiologic Licensing Application2020-10-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myocardial infarctionEFO_0000612D009203I21
ventricular dysfunctionD018754
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
B01: Antithrombotic agents
B01A: Antithrombotic agents
B01AD: Enzymes, antithrombotic
B01AD07: Reteplase
HCPCS
Code
Description
J2993
Injection, reteplase, 18.1 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
Inferior wall myocardial infarctionD056989EFO_100098322
Myocardial infarctionD009203EFO_0000612I21112
Heart diseasesD006331EFO_0003777I51.911
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
St elevation myocardial infarctionD00007265711
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
StrokeD020521EFO_0000712I63.911
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 nameRETEPLASE
INNreteplase
Description
Reteplase, trade names include Retavase, is a thrombolytic drug, used to treat heart attacks by breaking up the clots that cause them.
Classification
Enzyme
Drug classenzymes: tissue-type plasminogen activators
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID133652-38-7
RxCUI76895
ChEMBL IDCHEMBL2107885
ChEBI ID
PubChem CID
DrugBankDB00015
UNII IDDQA630RIE9 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 894 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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11 adverse events reported
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