Novartis: Tasigna GB prescribing information showed NI marketing authorisation numbers (AUTH/3732/1/23)

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Key facts

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Case	AUTH/3732/1/23
Complainant	Anonymous, non-contactable complainant (described as a health professional)
Company	Novartis Pharmaceuticals UK Ltd
Product	Tasigna (nilotinib)
Channel/material	Novartis UK HCP website (health.novartis.co.uk) link to prescribing information
Issue	NI marketing authorisation numbers included on a document headed “Great Britain Prescribing Information”
GB MA numbers that should have been shown	PLGB 00101/1152 (50mg); PLGB 00101/1150 (150mg); PLGB 00101/1151 (200mg)
Applicable Code	2021
Complaint received	27 January 2023
Case completed	5 April 2024
Appeal	No appeal
Rulings	Breach Clause 5.1; No breach Clause 5.1; No ruling under Clause 12.2
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous, non-contactable complainant (described as a health professional) complained about Tasigna (nilotinib) prescribing information linked from Novartis’ UK HCP website (health.novartis.co.uk).
The linked prescribing information (updated June 2022) was presented as separated for Great Britain (GB) and Northern Ireland (NI).
The document headed “Great Britain Prescribing Information: TASIGNA® (nilotinib)” included NI marketing authorisation numbers instead of GB numbers.
Novartis described this as a technical oversight/human error during approval and said it updated and re-certified the prescribing information within four working days, then replaced the link on the webpage.
The Authority asked Novartis to consider Clauses 12.2 (as cited by the complainant) and 5.1 (2021 Code).

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Breach: Clause 5.1 (Failing to maintain high standards).
No breach: Clause 5.1 (Requirement to maintain high standards) (the Panel considered an additional ruling was not warranted in the circumstances).
The Panel made no ruling under Clause 12.2 (and noted Clause 12.1 had not been cited, so it considered the matter under Clause 5.1).
No appeal.

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