Ulipristal Acetate Gedeon Richter
Withdrawn
This medicine's authorisation has been withdrawn
ulipristal acetate
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 14 June 2021, the European Commission withdrew the marketing authorisation for Ulipristal Acetate Gedeon Richter (ulipristal acetate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Gedeon Richter Plc., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Ulipristal Acetate Gedeon Richter was granted marketing authorisation in the EU on 27 August 2018 for the treatment of uterine fibroids. The marketing authorisation was initially valid for a 5-year period.
Ulipristal Acetate Gedeon Richter was a duplicate application to Esmya, which is marketed in several EU countries.
The European Public Assessment Report (EPAR) for Ulipristal Acetate Gedeon Richter is updated to indicate that the marketing authorisation is no longer valid.
Product information
14/06/2021
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ulipristal Acetate Gedeon Richter
- Active substance
- ulipristal acetate
- International non-proprietary name (INN) or common name
- ulipristal acetate
- Therapeutic area (MeSH)
- Leiomyoma
- Anatomical therapeutic chemical (ATC) code
- G03XB02
Pharmacotherapeutic group
Sex hormones and modulators of the genital systemTherapeutic 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.
Assessment history
News on Ulipristal Acetate Gedeon Richter
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