AstraZeneca breached Clause 9.5 by referencing the MHRA in a Zoladex journal advertisement (AUTH/2204/1/09)

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Key facts

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Case number	AUTH/2204/1/09
Complainant	Medicines and Healthcare products Regulatory Agency (MHRA)
Company	AstraZeneca UK Limited
Material	Zoladex (goserelin) journal advertisement
Ad reference	AZ-CZ000261b-ZOLU
Publication	The Pharmaceutical Journal
Publication date	17 January 2009
Complaint received	27 January 2009
Case completed	24 February 2009
Applicable Code year	2008
Breach	Yes
Clause(s)	Clause 9.5
Sanctions	Undertaking received
Appeal	No appeal

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

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The MHRA complained about a Zoladex (goserelin) journal advertisement issued by AstraZeneca UK Limited (ref AZ-CZ000261b-ZOLU) published in The Pharmaceutical Journal on 17 January 2009.
The ad stated that the MHRA had reviewed the licence for goserelin 3.6 mg and 10.8 mg and updated the SmPC to reflect survival benefits, and that Section 5.1 of the SmPC detailed survival data from randomised controlled trials.
The MHRA alleged that referencing the MHRA in promotional material breached the Code.
AstraZeneca accepted it was a genuine oversight, apologised, sought to stop further publication where possible, and proposed amending the text to remove direct reference to the MHRA.

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Breach found: Yes.
The Panel ruled AstraZeneca was in breach because the Code prohibited reference to the MHRA in promotional material unless specifically required by the licensing authority, which it was not.
No appeal.

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