Theramex congress booth discussion about linzagolix (Yselty): complaint about alleged off-label/availability promotion found no breach (AUTH/3902/5/24)

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Key facts

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Case number	AUTH/3902/5/24
Company	Theramex HQ UK Ltd
Complainant	Named, contactable complainant (doctor based in the UK)
Setting	Gynaecological endocrinology congress, Italy (May 2024); commercial booth
Product	Yselty (linzagolix)
Key allegation	Representative allegedly implied endometriosis use/near-term licence and that linzagolix was readily available; lack of clarity on licence and availability
Materials	No hardcopy provided; promotional panel observed by Panel (included licensed indication and “Non commercializzato in Italia - not marketed in Italy”)
Applicable Code	2021
Clauses considered	2, 5.1, 6.1 (x2), 11.1, 11.2, 17.2, 17.10
Decision	No breach of all clauses considered
Complaint received	10 May 2024
Case completed	30 June 2025
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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A UK-based doctor complained about an interaction at Theramex’s commercial booth at a gynaecological endocrinology congress in Italy (May 2024).
The complainant alleged the representative discussed endometriosis and ongoing trials, implied linzagolix (Yselty) would be licensed for endometriosis soon, and gave the impression it was readily available.
The complainant later understood linzagolix was not licensed for endometriosis and was not available for prescription in the UK and most European countries.
No hardcopy materials were provided; the complainant did not know the representative’s name and believed they were not a UK representative.
Theramex denied the allegations, said it could not identify the individual, and described pre-congress briefings/SOPs requiring booth conversations to stay within the licensed indication and unsolicited off-licence questions to be referred to medical via a medical information request process.
The Panel noted Yselty was licensed (uterine fibroids) at the time, but not licensed for endometriosis.
The Panel reviewed a promotional panel which stated the licensed indication and included “Non commercializzato in Italia - not marketed in Italy”.

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No breach of Clause 2.
No breach of Clause 5.1.
No breach of Clause 6.1 (x2).
No breach of Clause 11.1.
No breach of Clause 11.2.
No breach of Clause 17.2.
No breach of Clause 17.10.
The Panel said it was not possible to determine what had been said verbally and it had not been established that the representative misled the complainant or promoted inconsistently with the summary of product characteristics.

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Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
Clause 5.1 Requirement to maintain high standards at all times
Clause 6.1 (x2) Requirement that information, claims and comparisons must not be misleading
Clause 11.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
Clause 11.2 Requirement not to promote a medicine for an unlicensed indication
Clause 17.2 Requirement that representatives must maintain high standards of ethical conduct in the discharge of their duties and comply with all relevant requirements of the Code
Clause 17.10 Responsibility of companies for the activities of their representatives if these are within the scope of their employment even if they are acting contrary to the instructions which they have been given

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