AUTH/3904/5/24: Complainant v Gedeon Richter (Evra ad and linked e-detail pages) – No breach

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3904/5/24
CompanyGedeon Richter (UK) Ltd
ComplainantContactable complainant (described themselves as a healthcare professional)
ProductEvra (norelgestromin/ethinyl estradiol) transdermal patch
ChannelAdvertisement on a closed community professional network for doctors; linked e-detail aid website pages (‘Benefits’, ‘Safety & tolerability’)
Main allegationsMissing facets of indication; linked pages missing licensed indication and significant risks/contraindications; potential wider-than-licensed promotion; inadequate safety information
Applicable Code2021
Clauses considered2, 5.1, 6.1, 11.2
Panel decisionNo breach of Clauses 2, 5.1, 6.1 (x2), 11.2 (x2)
AppealNo appeal
Complaint received15 May 2024
Case completed4 June 2025

Download the full case report (PDF)


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

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What happened

  • A healthcare professional complained about an Evra (norelgestromin/ethinyl estradiol) promotional advertisement shown on a closed UK doctors’ network.
  • The complainant alleged the ad omitted “key facets” of the SmPC indication (including age range and VTE risk considerations) and therefore promoted to a wider audience than licensed.
  • The ad linked to an Evra e-detail aid website; the complainant alleged the linked ‘Benefits’ page did not state the licensed indication or “significant risks”.
  • The complainant also alleged the ‘Safety & tolerability’ page did not explicitly call out contraindications (SmPC section 4.3).
  • Gedeon Richter stated the prescribing information (PI) was available via a prominent single-click link from the ad and each webpage, and that a pop-up on the ‘Introducing EVRA’ page summarised warnings/precautions and contraindications with links to the SmPC.
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Outcome

  • No breach of Clause 2.
  • No breach of Clause 5.1.
  • No breach of Clause 6.1 (x2).
  • No breach of Clause 11.2 (x2).
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