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PMCPA Case

Astellas: Clinical trial disclosure (Betmiga) — No breach (outwith scope of the Code) (AUTH/2762/5/15)

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2762/5/15
PartiesParagraph 5.1/Director v Astellas
IssueClinical trial disclosure (Betmiga)
Complaint received14 May 2015
Completed09 July 2015
Applicable Code year2015
OutcomeNo breach; outwith the scope of the Code
Case reportNo case report (outwith scope)
Clauses citedNot stated
SanctionsNone stated

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

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What happened

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  • A complaint was brought by the Director under Paragraph 5.1 against Astellas.
  • The subject matter related to clinical trial disclosure for Betmiga.
  • The PMCPA concluded the matter was outwith the scope of the Code.
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Outcome

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  • No breach.
  • Case deemed outwith the scope of the Code.
  • No case report was issued because it was outwith scope.
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