Regulatory PathRegulatory requirements compared

Active substances

Dienogest + Estradiol

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
NATAZIAN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/Atablet · oralBAYER HLTHCAREPrescription6 May 2010
ESTRADIOL VALERATE AND DIENOGESTN/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/Atablet · oralWATSON LABS INCPrescription

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
QLAIRA, FILM-COATED TABLETSPL 00010/0576BAYER PLCPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNATAZIA 28 TABLET$8.46366per EA23 Sep 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.

Components

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.