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Defining a New Indication

An indication is a medical condition that a medicine is used for. This can include the treatment, prevention and diagnosis of a disease.

A new indication may be:

  • a new target disease;
  • different stages or severity of disease;
  • an extended target population for the same disease, e.g. based on a different age range or other intrinsic or extrinsic factors;
  • a change from first-line treatment to second-line treatment (or second-line to first-line treatment), or from combination therapy to monotherapy, or from one combination therapy (e.g. in the area of cancer) to another combination;
  • change from treatment to prevention or diagnosis of a disease;
  • change from treatment to prevention of progression of a disease or to prevention of relapses of a disease;
  • change from short-term treatment to long-term maintenance therapy in chronic disease.
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