Highlights of Prescribing Information | PharmaBharat Tools

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Highlights of Prescribing Information | PharmaBharat Tools

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RA LabelingHighlights of Prescribing Information

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Company Core Data Sheet (CCDS)Instructions for Use (IFU)

Highlights of Prescribing Information

Labeling

Definition

A concise summary section of the US PI in PLR format that provides key information for safe and effective use.

Regulatory source

21 CFR 201.57; Physician Labeling Rule (PLR)