Regulatory PathRegulatory requirements compared

Active substance

Ulipristal

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Ecinq30 mgFilm-coated tablet · Oral use1 BlisterSAR 51.15Generic · OTCAspen HealthcareValid
ESMYA 5 MG TABLET5 mgTablet · Oral use28 BlisterSAR 432.90NCE · PrescriptionFerring GmbHWithdrawn by regulatory authority · Not Marketed
Indications — CHI Daman Drug Formulary

CONTRACEPTION

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ELLA30MGtablet · oralLAB HRA PHARMAPrescription13 Aug 2010
LOGILIA30MGtablet · oralTEVA PHARMS USAPrescription13 Feb 2017

EMA European Union — centrally authorised medicines

ellaOne Laboratoire HRA Pharma · Authorised · authorised 15 May 2009 · ATC G03AD02

Therapeutic indication (EMA)

Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.

Esmya Gedeon Richter Ltd · Withdrawn · authorised 22 Feb 2012 · ATC G03XB02

Therapeutic indication (EMA)

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.

Ulipristal Acetate Gedeon Richter Gedeon Richter Plc. · Withdrawn · authorised 27 Aug 2018 · ATC G03XB02

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ELLA0243632930 MGTABLET · ORALLABORATOIRE HRA PHARMA

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACELLA 30 MG TABLET$37.09804per EA23 Sep 2026
NHS Drug TariffUlipristal 30mg tablets£16.581 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 22.1.1. Oral hormonal contraceptives · core
    Contact with health services for postcoital contraception
    Oral > Solid: 30 mg tablet (ulipristal acetate)

Safety signals and safety-related labeling changes

  • US FDA 24 Jun 2021 ELLA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ulipristal →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.