This page provides the primary authoritative and scientific sources used to support the medical information on this website.
Regulatory Sources
U.S. Food and Drug Administration — TAGRISSO (osimertinib) prescribing information
The FDA-approved labeling provides information on indications, dosage, administration, warnings, adverse reactions, drug interactions, pharmacology and clinical studies.
DailyMed — TAGRISSO (osimertinib)
DailyMed provides the U.S. labeling record and structured prescribing information.
European Medicines Agency — Tagrisso EPAR
The EMA provides European regulatory information, indications, safety information and authorization history.
Clinical Literature
PubMed — Mechanisms of resistance to osimertinib
Reviews acquired resistance mechanisms including EGFR-dependent and EGFR-independent resistance.
PubMed — Osimertinib CNS activity
Reviews CNS penetration and activity in EGFR-mutated NSCLC.
PubMed — Osimertinib review
Reviews the pharmacology and clinical development of osimertinib.
Manufacturer Sources
Everest Pharmaceuticals Ltd. — Osimert product listing
The manufacturer’s product catalogue identifies Osimert as osimertinib INN 80 mg.
Everest Pharmaceuticals Ltd. — Company information
Provides corporate and manufacturing information.
Safety Updates
European Medicines Agency / PRAC — hepatitis B reactivation wording
The 2025 safety communication contains updated product-information wording regarding hepatitis B reactivation with osimertinib.
Reference hierarchy
For prescribing decisions, the latest official regulatory label applicable to the patient’s jurisdiction should take priority over secondary websites.