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A pediatric study of Terbinafine for the treatment of Onychomycosis

Trial Profile

A pediatric study of Terbinafine for the treatment of Onychomycosis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2021

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At a glance

  • Drugs Terbinafine (Primary)
  • Indications Onychomycosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Moberg Pharma
  • Most Recent Events

    • 27 Oct 2021 New trial record
    • 22 Oct 2021 According to a Moberg Pharma media release, company has received approval of the pediatric plan for MOB-015 from EMA's paediatric committee (PDCO).This approval enables the company to pursue a full marketing authorization application providing up to ten years of exclusivity in Europe following approval. The company's timeline remains, with planned submission for MOB-015 in Europe this year and expected market approval in 2023.
    • 22 Sep 2021 According to a Moberg Pharma media release, this study will be initiated in the second half of 2022.
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