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
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 |
|---|---|---|---|---|---|
| Retavase | reteplase | Chiesi USA, Inc. | N-103786 RX | 1996-10-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| retavase | Biologic Licensing Application | 2020-10-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myocardial infarction | EFO_0000612 | D009203 | I21 |
| ventricular dysfunction | — | D018754 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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 infarction | D056989 | EFO_1000983 | — | — | — | 2 | — | 2 | |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | 1 | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| St elevation myocardial infarction | D000072657 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | — | 1 |
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 name | RETEPLASE |
| INN | reteplase |
| 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 class | enzymes: tissue-type plasminogen activators |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 133652-38-7 |
| RxCUI | 76895 |
| ChEMBL ID | CHEMBL2107885 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00015 |
| UNII ID | DQA630RIE9 (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:
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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
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11 adverse events reported
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