AUTH/2675/11/13: Member of the public v Eisai (Halaven) — complaint out of scope, no breach | PMCPA Case

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Key facts

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Case number	AUTH/2675/11/13
Complainant	Member of the public
Company	Eisai
Product	Halaven
Issue	Clinical trial disclosure
Complaint received	18 November 2013
Completed	20 March 2014
Applicable Code year	2012
Review	No Review as outwith the scope of the Code
Outcome	No breach (outwith the scope of the Code)
Additional sanctions	Not stated

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

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A member of the public made a complaint about clinical trial disclosure relating to Halaven.
The complaint was considered under the 2012 ABPI Code of Practice.
The PMCPA determined the issue was outwith the scope of the Code.

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No breach was found.
No case report was issued because the matter was outwith the scope of the Code.
No review took place (recorded as “No Review as outwith the scope of the Code”).

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