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Pan Am Farma

TECENTRIQ® (atezolizumab) 1200 mg

Product Overview
Generic NameTECENTRIQ® (atezolizumab) 1200 mg
Brand Name(s)Tecentriq®
Product TypeOriginator Brand
FormIntravenous injection (liquid, vial)
Strength1200 mg vial
Therapeutic ClassPD‑L1 inhibitor immunotherapy
ATC CodeL01XC32
Manufacturing & Regulatory
ManufacturerHoffmann‑La Roche / Genentech
CountrySwitzerland (Roche HQ); in USA (Genentech) & global
GMP ComplianceFDA/EMA/WHO-GMP
DMF/CEPNot public—Type II for biologics
COFEPRIS010.000.6193.00
Free Sale Certificatemay obtain export certificate from regulatory authority
Logistics & Export
MOQ5 vials
Shelf Life24 Months
Storage2 – 8 °C cold chain
IncotermsEXW/FOB/CIF negotiable
Lead Time10–21 days
Documentation
Certificate of Analysis (COA)Supplied by Roche/Genentech; distributors also issue COA
SDSUpon Request
CTD SummaryCTD proprietary; available under commercial agreement/license

Description

Indications & Usage: Fully human IgG1 anti-PD‑L1 monoclonal antibody indicated in adults for: Urothelial carcinoma (initial indication), Advanced NSCLC (monotherapy and in combination regimens) Extensive-stage SCLC (with chemo) Hepatocellular carcinoma (with bevacizumab) and also approved for metastatic melanoma, alveolar soft part sarcoma; first PD‑L1 antibody worldwide

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