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PURPOSE

Govern medical information responses for the authorised product in EU NSCLC, defining on-label versus medical affairs review boundaries.

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DOSING GUIDANCE

On-label dosing inquiries use approved EU label content: 80 mg once daily first-line metastatic NSCLC for the authorised product. Dose reductions must remain within approved EU label boundaries.

Inquiries probing off-label dosing or regimens route to SME review.

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MEDICAL RESPONSE RULES

Label is primary for indication, dose, and contraindications. Conflicts resolve in favour of the label. Low-confidence or policy-sensitive items route to SME.