Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Methodology|Interests|Funding|Corrections
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Defined term · Regulatory

Off-label

Use of an authorised product outside the terms of its authorisation. A regulated product used outside its licence, and distinct from an unapproved product, though the two are frequently conflated.

Document identifier
CEI-GT-177
Series
Defined term
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Off-label

§1.2Category

Regulatory — Terms describing the status of a compound before a competent authority.

§1.3Related terms

  • Marketing authorisation — Permission from a competent authority to place a medicine on the market for a stated indication. Specific to product, indication, presentation and jurisdiction.
  • Unapproved — Holding no marketing authorisation for the use in question. A compound may be approved in one indication and unapproved in another, and approved in one jurisdiction and…
Compound Evidence Institute · CEI-GT-177 · https://compoundevidence.com/glossary/off-label/ · retrieved 30 July 2026
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