CASE/0270/08/24 - Complainant v Theramex

Alleged promotion of an unauthorised indication for linzagolix

  • Received
    14 August 2024
  • Case number
    CASE/0270/08/24
  • Applicable Code year
    2021
  • Completed
    14 May 2025
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
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  • Appeal
    No appeal

Case Summary

This case was in relation to a Theramex-sponsored symposium and exhibition stand relating to Yselty (linzagolix). The complainant alleged that information presented at the World Congress of Endometriosis created the misleading impression that linzagolix had obtained a licensed indication for the treatment of endometriosis.

The outcome under the 2021 Code was:

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 6.1 (x2)

Providing misleading information

Breach of Clause 11.2 (x2)

Promoting a medicine for an unlicensed indication

 

No Breach of Clause 11.1

Requirement that a medicine must not be promotion prior to the grant of its marketing authorisation

This summary is not intended to be read in isolation.
For full details, please see the full case report below.