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PMCPA Case

AUTH/3000/12/17: Director v Roche (Gazyvaro) – Clinical trial disclosure

📅 2017 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/3000/12/17
PartiesDirector v Roche
ProductGazyvaro
IssueClinical trial disclosure
Complaint received20 December 2017
Completed06 March 2018
Applicable Code year2016
DecisionNo breach; outwith the scope of the Code; no report; out of scope
Clauses citedNot stated
SanctionsNot stated
Sourcehttps://www.pmcpa.org.uk/cases/completed-cases/auth30001217-director-v-roche

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

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What happened

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  • A case was brought by the PMCPA Director against Roche.
  • The subject matter related to clinical trial disclosure for Gazyvaro.
  • The case was assessed under the 2016 ABPI Code of Practice.
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Outcome

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