Rituximab Hycela 1,600mg/26,800U 13.4mL
Product Overview | |
Generic Name | Rituximab Hycela 1,600mg/26,800U 13.4mL |
Brand Name(s) | Rituxan, Mabthera |
Form | Sub-C |
Strength | 1,600 mg rituximab / 26,800 units hyaluronidase per 13.4 mL, Sub-C |
Therapeutic Class | Monoclonal antibody targeting CD20 (antineoplastic/immunomodulator) |
ATC Code | L01FA01 |
Manufacturing & Regulatory | |
Manufacturer | Biogen/Genentech/Roche |
Country | India/USA/EU |
GMP Compliance | WHO-GMP |
DMF/CEP | Type II |
COFEPRIS | Batch-specific |
Free Sale Certificate | Yes |
Logistics & Export | |
MOQ | 5 units |
Shelf Life | 24 months |
Storage | 2–8 °C |
Incoterms | Ex-Works Mexico |
Lead Time | 7 to 10 Days |
Documentation | |
Certificate of Analysis (COA) | Yes |
SDS | Upon Request |
CTD Summary | Full CTD for originator; generics abridged |
Description
Indications & Usage: FL (relapsed/refractory); previously untreated FL (with chemo + maintenance); non-progressing FL post-CVP; previously untreated DLBCL (with CHOP); treated/untreated CLL (with FC) — only after ≥1 full IV rituximab dose