AbbVie breach for inaccurate SPC presentation on EMC: missing dash in Venclyxto dosing schedule (AUTH/3871/1/24)

📊

Key facts

⌄

Case number	AUTH/3871/1/24
Company	AbbVie
Complainant	Anonymous, non-contactable complainant (described themselves as a health professional)
Product	Venclyxto (venetoclax) 100mg film-coated tablets (also affected: 50mg; not affected: 10mg)
Channel/material	SPC on Electronic Medicines Compendium (EMC) website (published by a third party on behalf of AbbVie)
Issue	Missing dash in AML dosing schedule: “Days 1 7” shown instead of “Days 1-7” for azacitidine administration
Applicable Code	2021
Complaint received	18 January 2024
Case completed	10 February 2025
Panel outcome	Breach Clause 5.1; No breach Clause 2
Sanctions	Undertaking received; Additional sanctions: Not stated
Appeal	No appeal

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

⌄

An anonymous, non-contactable health professional complained about a formatting error in the Venclyxto (venetoclax) 100mg SPC on the EMC website.
In section 4.2 (Posology and method of administration) for AML, azacitidine dosing appeared as “Days 1 7 of each 28-day cycle” instead of “Days 1-7”.
The complainant alleged the missing dash could be misread as “Days 17”, potentially causing confusion and incorrect dosing.
AbbVie confirmed the missing dash on EMC for Venclyxto 100mg and also identified the same issue on the 50mg SPC; the 10mg SPC did not have the error.
AbbVie stated the versions it submitted to the EMC third party were correct and aligned with MHRA-approved versions; the error likely arose during document conversion by the third party.
AbbVie relied on the third party’s QC process, which had passed without flags for missing/incorrect symbols.
AbbVie contacted the third party to correct the EMC versions; the third party confirmed the errors were resolved and said it would take steps to prevent recurrence.
The Panel considered whether SPC presentation on a third-party platform (EMC) was within scope of the Code and concluded it was.

⚖️

⌄

Breach of Clause 5.1 (Failing to maintain high standards).
No breach of Clause 2 (Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry).
The Panel found the error had been present on EMC for almost a year (SPCs published 1–2 February 2023; complaint received 18 January 2024) and only came to AbbVie’s attention after the complaint.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access