Overview
Methoxy polyethylene glycol-epoetin beta is a chemically synthesised Erythropoiesis Stimulating Agent (ESA) with a longer half-life than erythropoietin. ESA is used to increase synthesis of red blood cells to treat chronic kidney disease associated anemia.
Indication
For the treatment of patients with anaemia associated with chronic kidney disease. Not a substitute for RBC transfusion if immediate correction of anemia is required.
Associated Conditions
- Anemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/01/13 | Phase 3 | Completed | |||
2019/11/07 | Phase 3 | Completed | |||
2018/06/11 | Phase 2 | Completed | |||
2015/09/11 | N/A | Completed | |||
2014/10/13 | N/A | Completed | |||
2014/09/12 | N/A | Completed | |||
2014/09/05 | Phase 4 | Completed | |||
2014/01/30 | Phase 4 | Completed | |||
2014/01/24 | Phase 2 | Completed | |||
2013/03/08 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Vifor (International) Inc. | 59353-404 | INTRAVENOUS | 150 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-406 | INTRAVENOUS | 250 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-403 | INTRAVENOUS | 100 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-408 | INTRAVENOUS | 360 ug in 0.6 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-407 | INTRAVENOUS | 120 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-401 | INTRAVENOUS | 50 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-402 | INTRAVENOUS | 75 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-405 | INTRAVENOUS | 200 ug in 0.3 mL | 10/12/2023 | |
| Vifor (International) Inc. | 59353-400 | INTRAVENOUS | 30 ug in 0.3 mL | 10/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/20/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Mircera Solution for Injection 75mcg/0.3ml (Pre-filled Syringe) | SIN13530P | INJECTION, SOLUTION | 75 mcg/0.3ml | 8/19/2008 | |
| Mircera Solution for Injection 100mcg/0.3ml (Pre-filled Syringe) | SIN13529P | INJECTION, SOLUTION | 100mcg/0.3ml | 8/19/2008 | |
| Mircera Solution for Injection 50mcg/0.3ml (Pre-filled Syringe) | SIN13535P | INJECTION, SOLUTION | 50mcg/0.3ml | 8/19/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MIRCERA INJ 50MCG/0.3ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 3/25/2008 | |
| MIRCERA INJ 200MCG/0.3ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 3/25/2008 | |
| MIRCERA INJ 100MCG/0.3ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 3/25/2008 | |
| MIRCERA INJ 150MCG/0.3ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 3/25/2008 | |
| MIRCERA INJ 75MCG/0.3ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 3/25/2008 |
TGA Drug Approvals
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