Mircera(methoxy polyethylene glycol-epoetin beta)
Mircera (methoxy polyethylene glycol-epoetin beta) is a protein pharmaceutical. Methoxy polyethylene glycol-epoetin beta was first approved as Mircera on 2007-07-20. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia and chronic kidney failure.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Mircera
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)
Methoxy polyethylene glycol-epoetin beta
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Mircera | methoxy polyethylene glycol-epoetin beta | Vifor | N-125164 RX | 2007-11-14 | 9 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mircera | Biologic Licensing Application | 2019-08-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | EFO_0004272 | D000740 | D64.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
86 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 8 | 40 | 11 | 4 | 63 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | 1 | — | — | — | 1 | |
| Lung neoplasms | D008175 | C34.90 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Reticulocyte count | D017701 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA |
| INN | — |
| Description | Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).
|
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707314 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09107 |
| UNII ID | — |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Mircera - Roche
$
€
£
₣
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 186 documents
View more details
Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
7,755 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more