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Esmya® long-term indication in EU

Esmya® is approved in the European Union for long-term management of symptomatic uterine fibroids1

Esmya® long-term indication in EU

Esmya® is approved in the European Union for long-term management of symptomatic uterine fibroids1.

  • Esmya® (Ulipristal acetate 5mg) is now indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age7.
  • The efficacy and safety of intermittent treatment with Esmya® has been confirmed in the recent PEARL III extension and PEARL IV studies 7,44.
  • Esmya® is effective for bleeding control and reduction in fibroid volume7.
  • Efficacy of Esmya® is maintained even during off-treatment periods and is well tolerated7.

References

  • 125 Reference 1 - Esmya® SmPC. May 2015.
  • 480 Reference 7 - Donnez J, et al. Fertil Steril 2016;105(1):165-173. e4 [PEARL IV PART 2]
  • 2908 Reference 44 – Donnez J, et al. Long-term treatment of uterine fibroids with Ulipristal Acetate. Fertil Steril 2014;101(6):1565-1573. [PEARL III]
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