Esmya (ulipristal)
- Region
- 🇪🇺 EU
- Active substance
- ulipristal
- Company
- Gedeon Richter Ltd
- Status
- Withdrawn
- Therapeutic area
- Leiomyoma
- CHMP opinion
- Thu 15 Dec 2011
- EU approval
- Wed 22 Feb 2012
- Application
- EMEA/H/C/002041
- ATC
- G03XB02
- Official record
- www.ema.europa.eu
Indication
Ulipristal acetate is indicated for 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 ellaOne Authorised · Laboratoire HRA Pharma
- 🇪🇺 Ulipristal Acetate Gedeon Richter Withdrawn · Gedeon Richter Plc.
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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.