Britannia Pharmaceuticals: “Apo-go Pump” branding ruled misleading (AUTH/3377/9/20)

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Key facts

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Case number	AUTH/3377/9/20
Complainant	Employee
Company	Britannia Pharmaceuticals Limited
Product	Apo-go (apomorphine)
Issue	Misleading use of “Apo-go Pump” name/logo; product not supplied as a pump and branding inconsistent with SPC
Applicable Code year	2019
Complaint received	10 September 2020
Case completed	18 February 2021
Appeal	No appeal
Breach clauses	Clause 3.2; Clause 7.2; Clause 9.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An employee complained that Britannia’s promotion and branding referred to “Apo-go Pump”, which the complainant said was non-compliant with the SPC and had been incorrect for years.
Britannia said it was alerted on 13 August 2020 that the historical “Apo-go Pump” branding was inconsistent with the SPC (apparently flagged during an MHRA inspection).
Apo-go (apomorphine) was supplied as a pre-filled pen for injection, ampoules for injection/infusion, and pre-filled syringes as a solution for infusion—not as a pump.
SPCs stated administration could be via continuous subcutaneous infusion using a minipump and/or syringe-driver, with device choice determined by the physician; however, the medicine itself was not supplied as a pump.
Britannia placed relevant promotional materials on hold in its warehouse (14 August 2020), withdrew six promotional items in late August, and put websites featuring the historical logo “under maintenance” pending recertification.
Britannia did not immediately withdraw certain patient and health professional materials related to use of the Crono Pump III and patient support, stating patient support/safety concerns; it planned to update and reissue materials (target 16 October 2020).
Britannia acknowledged breaches of Clauses 3.2, 7.2 and 9.1.

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The Panel ruled that use of the “APO-go pump” logo and references to “Apo-go pump” were misleading and inconsistent with the SPC particulars.
Breaches were ruled for misleading promotion and for failure to maintain high standards, including concerns about certification oversight and delayed withdrawal of some affected materials.
No appeal.

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