Pegfilgrastim 6mg/0.6mL pfs
| Product Overview | |
| Generic Name | Pegfilgrastim 6mg/0.6mL pfs |
| Brand Name(s) | Neulasta®, Neulastim® |
| Form | PFS, Solution for subcutaneous injection. |
| Strength | 6mg / 0.6 mL = 10mg/mL protein concentration |
| Therapeutic Class | Long-acting granulocyte colony-stimulating factor / G-CSF; immunostimulant; leukocyte growth factor. |
| ATC Code | L03AA13 |
| Manufacturing & Regulatory | |
| Manufacturer | Amgen Inc |
| Country | Puerto Rico, Netherlands |
| GMP Compliance | WHO-GMP |
| COFEPRIS | 010.000.5452.01 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 months |
| Storage | 2–8 °C, protect from light |
| Incoterms | EXW, HS 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Pegfilgrastim is a long-acting G-CSF used to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive cytotoxic chemotherapy associated with clinically significant febrile-neutropenia risk. It is administered subcutaneously, typically as a fixed 6 mg dose at least 24 hours after chemotherapy, under oncology/haematology supervision. It is not indicated for mobilisation of peripheral blood progenitor cells for haematopoietic stem-cell transplantation.
