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Evidence
Off-label
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Off-label - Using an approved medicine outside its official approval - e.g. for a different indication or dose than the one tested.
Also called off labeloff-label usebeyond approval
Off-label means using an approved medicine outside its authorized conditions - e.g. for a different disease, age group or dose than the one it was tested and approved for.
An important distinction
Off-label presupposes an approved product. A never-approved grey-market substance is not „off-label" but simply unapproved - an important difference in risk profile.