Ulipristal Acetate Gedeon Richter (ulipristal acetate)
- Region
- 🇪🇺 EU
- Active substance
- ulipristal acetate
- Company
- Gedeon Richter Plc.
- Status
- Withdrawn
- Therapeutic area
- Leiomyoma
- CHMP opinion
- Thu 28 Jun 2018
- EU approval
- Mon 27 Aug 2018
- Application
- EMEA/H/C/005017
- ATC
- G03XB02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 ellaOne Authorised · Laboratoire HRA Pharma
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.