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A multicenter, multinational, prospective observational post-authorization safety study of loxapine [Adasuve] in patients with agitation

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Trial Profile

A multicenter, multinational, prospective observational post-authorization safety study of loxapine [Adasuve] in patients with agitation

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 19 Jun 2015

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At a glance

  • Drugs Loxapine (Primary)
  • Indications Agitation
  • Focus Adverse reactions
  • Acronyms PASS
  • Sponsors Alexza Pharmaceuticals

Most Recent Events

  • 18 Jun 2015 According to a media release, Alexza Pharmaceuticals plans to transfer the EU Marketing authorization for ADASUVE (MAA) to Ferrer. The MAA transfer includes the responsibilities for the ongoing post-approval clinical studies (the PASS and DUS studies), a planned phase III trial in adolescents [see CT profile 700257964] and ongoing pharmacovigilance responsibilities.
  • 14 Oct 2014 New trial record

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