Actavis: Clinical trial disclosure query for Zinforo/Teflaro ruled outwith PMCPA scope (AUTH/2772/6/15)

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2772/6/15
PartiesParagraph 5.1/Director v Actavis
IssueClinical trial disclosure (Zinforo (marketed as Teflaro in USA))
Complaint received11 June 2015
Completed10 July 2015
Applicable Code year2015
DecisionNo breach; outwith the scope of the Code
Report statusNo case report as outwith the scope of the Code
SanctionsNone stated

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

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What happened

  • A matter was raised under Paragraph 5.1 by the PMCPA Director against Actavis.
  • The issue related to clinical trial disclosure for Zinforo (marketed as Teflaro in the USA).
  • The PMCPA determined the matter was outwith the scope of the ABPI Code of Practice.
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Outcome

  • No breach (outwith the scope of the Code).
  • Review: No case report as outwith the scope of the Code.
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