AUTH/2340/7/10: Novartis v Dexcel Pharma – Deximune switching claims omitted required monitoring | PMCPA Case

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Key facts

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Case number	AUTH/2340/7/10
Parties	Novartis Pharmaceuticals UK Ltd v Dexcel Pharma Limited
Medicine	Deximune (ciclosporin); comparator referenced: Neoral (ciclosporin)
Materials	Mailing “Ciclosporin Prescribing in the UK The Facts” (DEX/10/0013); Detail aid (DEX/10/0001) available online
Main issue	Emphasis on “no dose adjustment” when switching, with insufficient/absent SPC-required close monitoring information (ciclosporin blood concentrations, serum creatinine, blood pressure)
Applicable Code year	2008
Complaint received	29 July 2010
Case completed	03 September 2010
Breach clauses	Clause 3.2 (x2) and 7.2 (x2)
Appeal	No appeal
Sanction	Undertaking received

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

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Novartis complained about Dexcel Pharma’s promotion of Deximune (ciclosporin) via a mailing (DEX/10/0013) and an online detail aid (DEX/10/0001).
The materials stated patients could be started on, or switched to, Deximune from Neoral “without the need for dose adjustment”, with visual emphasis in the mailing.
Novartis argued this presentation/omission failed to adequately alert readers to the SPC requirement for close monitoring when switching between oral ciclosporin formulations (ciclosporin blood concentrations, serum creatinine and blood pressure).
The mailing was used at a conference and circulated to the transplantation community (including pharmacists); the detail aid was available online to health professionals.
Dexcel defended the mailing but did not contest the complaint about the detail aid and agreed to stop distributing it.

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Breach found for both the mailing and the detail aid.
The Panel ruled the materials were misleading by omission/implication regarding precautions required when switching brands.
The Panel ruled the claims were not consistent with the particulars in the Deximune SPC/marketing authorisation.
No appeal.

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