Therapeutic indication

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Therapeutic indications are a description of the disease to be treated with a medicine, and the population for which the medicine is intended. They include the specifics about the disease, and restrictions to the patient population such as age, and whether the medicine is intended for symptom relief, cure or prevention, or whether it is for diagnostic use only.

Example statements from therapeutic indications:

  • Symptomatic treatment of mild to moderately severe Alzheimer’s disease.
  • Active substance X 40 mg is indicated for the prevention of post-operative nausea and vomiting (PONV) in adults.

Therapeutic indications must be clearly and concisely stated within the summary of product characteristics (SmPC) document that each medicine requires in the EU.

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