TAGRISSO® (osimertinib) 80mg
| Product Overview | |
| Generic Name | TAGRISSO® (osimertinib) 80mg |
| Brand Name(s) | Tagrisso® |
| Product Type | Originator Brand |
| Form | 30 Film-coated oral tablet |
| Strength | 80mg |
| Therapeutic Class | EGFR tyrosine kinase inhibitor; third-generation EGFR TKI |
| ATC Code | L01EB04 |
| Manufacturing & Regulatory | |
| Manufacturer | AstraZeneca |
| Country | UK/Sweden |
| GMP Compliance | FDA/EMA/WHO-GMP |
| COFEPRIS | 010.000.6173.00 |
| Free Sale Certificate | Available from manufacturer/exporter upon request |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Manufacturer provides COA |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Osimertinib is a once-daily oral EGFR kinase inhibitor for EGFR-mutated non-small cell lung cancer, including adjuvant treatment after tumor resection, metastatic EGFR exon 19 deletion or exon 21 L858R NSCLC, T790M-positive disease after prior EGFR TKI, and locally advanced unresectable stage III EGFR-mutated NSCLC after chemoradiation
