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Levonorgestrel - Bayer Healthcare Pharmaceuticals

Drug Profile

Levonorgestrel - Bayer Healthcare Pharmaceuticals

Alternative Names: BAY86-5028; Levonorgestrel IUS; Levonova; LNG IUS; LNG-IUS - Bayer; Menopausal levonorgestrel system; Mirena; MLS

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Schering Oy
  • Developer Bayer HealthCare Pharmaceuticals
  • Class Hormonal contraceptives; Hormonal replacements; Norpregnanes; Progesterone congeners; Small molecules
  • Mechanism of Action Progesterone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Menorrhagia; Pregnancy; Uterine diseases
  • No development reported Menopausal syndrome

Most Recent Events

  • 16 May 2023 Efficacy data from a clinical trial in menorrhagia released by Bayer
  • 19 Aug 2022 The US FDA approves a supplemental new drug application (sNDA) of intrauterine device 52mg levonorgestrel-releasing intrauterine system for up to 8 years in Pregnancy (Prevention) in USA (Intrauterine)
  • 18 Aug 2022 Efficacy and adverse events data form phase III MET extension trial released by Bayer
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