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PMCPA Case

Astellas UK: Clinical trial disclosure (Xtandi) — No breach / outwith scope (AUTH/2909/11/16)

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2909/11/16
PartiesDirector v Astellas UK
ProductXtandi
IssueClinical trial disclosure
Complaint received07 March 2017
Completed07 March 2017
DecisionNo breach; outwith the scope of the Code
Clauses citedNot stated
SanctionsNot stated
Additional sanctionsNot stated

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

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What happened

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  • The Director raised a complaint against Astellas UK.
  • The issue related to clinical trial disclosure concerning Xtandi.
  • The case was recorded as completed on the same date it was received.
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Outcome

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  • No breach.
  • Outwith the scope of the Code.
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