Epoetin beta (erythropoietin beta) recombinant human erythropoietin
| Product Overview | |
| Generic Name | Epoetin beta (erythropoietin beta) recombinant human erythropoietin |
| Brand Name(s) | NeoRecormon |
| Form | Solution for injection in pre-filled syringe |
| Strength | 5,000 IU |
| Therapeutic Class | Recombinant erythropoietin; erythropoiesis-stimulating agent; antianaemic |
| ATC Code | B03XA01 |
| Manufacturing & Regulatory | |
| Manufacturer | Roche, Biosimilars |
| Country | Germany, Mexico, India |
| GMP Compliance | WHO-GMP |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 Units |
| Shelf Life | 24 Months |
| Storage | Store refrigerated at 2–8 °C. |
| Incoterms | EXW, HS 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Epoetin beta is a recombinant human erythropoietin used to stimulate red-blood-cell production. It is indicated for symptomatic anaemia associated with chronic kidney disease in adults and paediatric patients, prevention of anaemia in premature infants, treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy, and increasing autologous blood yield before surgery where locally approved. Use requires physician supervision, haemoglobin monitoring, blood-pressure control, iron-status assessment, and risk evaluation for thromboembolic and tumour-progression concerns in oncology patients.
Available Dosages: 500 IU, 2,000 IU, 3,000 IU, 4,000 IU, 5,000 IU, 6,000 IU, 10,000 IU, 20,000 IU, 30,000 IU & 50,000 IU
