🇪🇺 PGL4001 in European Union

EMA authorised PGL4001 on 27 August 2018

Marketing authorisation

EMA — authorised 27 August 2018

  • Application: EMEA/H/C/005017
  • Marketing authorisation holder: Gedeon Richter Plc.
  • Local brand name: Ulipristal Acetate Gedeon Richter
  • Indication: Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
  • Status: withdrawn

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Frequently asked questions

Is PGL4001 approved in European Union?

Yes. EMA authorised it on 27 August 2018.

Who is the marketing authorisation holder for PGL4001 in European Union?

Gedeon Richter Plc. holds the EU marketing authorisation.