AUTH/3646/5/22 - Complainant v Roche

Concerns about dosing considerations website for Rozlytrek

  • Received
    12 May 2022
  • Case number
  • Applicable Code year
  • Completed
    23 May 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to the dosing webpage of the Rozlytrek (entrectinib) promotional website which missed important information about dose modifications included in the Rozlytrek summary of product characteristics (SPC) that were required to ensure appropriate prescribing and patient safety.

The Panel ruled a breach of the following Clauses of the 2021 Code because the dosing webpage, which was intended to advise health professionals on the appropriate
administration of the medicine, gave the misleading impression that it contained all the important information health professionals needed to prescribe Rozlytrek in patients with congestive heart failure or QT interval prolongation, elevated ALT and AST, central nervous system adverse reactions, and hyperuricaemia, anaemia or neutropenia which was not so. Noting that Rozlytrek was a black triangle medicinal product subject to additional monitoring, and that important safety information was omitted from the dosing webpage, the Panel considered that Roche had failed to maintain high standards and had brought discredit upon and reduced confidence in the pharmaceutical industry.

Breach of Clause 6.1

Providing misleading information

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 2

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

The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that there were no allegations that the information was not capable of substantiation and the complainant had not established that the webpage gave misleading information regarding fractures or that the information regarding fractures was not substantiated.

No Breach of Clause 6.1

Requirement that information must not be misleading

No Breach of Clause 6.2

Requirement that information must be capable of substantiation


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