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  Category Typical Characteristics
  
  
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  Product Overview Short description of the active ingredient(s), intended use, and benefit.
  
  
  
  
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  Regulatory Status Must be registered as a prescription or therapeutic drug; cannot be sold over‑the‑counter.
  
  
  
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  Clinical Evidence Summaries of key trials demonstrating efficacy
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  Packaging & Labeling Must include physician prescription label; patient information leaflet in local language(s).
  
  
  
  Storage Conditions Temperature range (e.g., 2–8 °C), shelf life,
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  ---
  
  
  
  
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  Prepared by:
  
  Pharmacovigilance Officer Name
  
  Date: Insert Date
  
  
  
  ---
  
  
  
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