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Rituximab Hycela 1,400mg/23,400U SC
Product Overview
| Generic Name | Rituximab Hycela 1,400mg/23,400U SC |
| Brand Name(s) | Rituxan, Mabthera |
| Category | Antineoplastic / Cancer |
| Form | Intravenous solution, concentrate for infusion |
| Strength | 1,400 mg rituximab / 23,400 units hyaluronidase per 11.7 mL, Sub-C |
| Therapeutic Class | Monoclonal antibody targeting CD20 (antineoplastic/immunomodulator) |
| ATC Code | L01FA01 |
Manufacturing & Regulatory
| Manufacturer | Biogen/Genentech/Roche |
| 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 Available Upon Request
| Certificate of Analysis (PDF) | Yes |
| SDS-Safety Data Sheet (PDF) | Upon Request |
| CTD Summary (PDF) | Full CTD for originator; generics abridged |
Special Notes
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