CASE/0244/07/24 - Complainant v GSK

Allegations regarding Omjjara prescribing information

  • Case number
    CASE/0244/07/24
  • Complaint received
    23 July 2024
  • Completed
    12 March 2025
  • Appeal hearing
    No appeal
  • Applicable Code year
    2021
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
    Advertisement

Case Summary

This case was in relation to wording about the use of hormonal contraceptives in the prescribing information for Omjjara (momelotinib), which was contraindicated in pregnancy.

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

Producing misleading information

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