Advert - Theramex UK LTD – CASE/0265/08/24

For failure to state the contraindication in pregnancy on Yselty (linzagolix) advertising material at a reproduction and embryology conference, coupled with an inaccurate indication statement on the stand and missing obligatory information, THERAMEX UK LTD was ruled in breach of the following clauses of the 2021 Code:

Clause 2         - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

Clause 5.1      - Failing to maintain high standards

Clause 6.1      - Providing misleading information

Clause 11.2    - Promotion inconsistent with the SPC

Clause 12.1    - Failing to include prescribing information

Clause 12.9    - Failing to include an adverse event reporting statement

On receipt of the Appeal Board’s ruling, THERAMEX UK LTD communicated that it would no longer accept the jurisdiction of the PMCPA and left self-regulation. The Medicines and Healthcare products Regulatory Agency (MHRA) were informed of the position.