Regulatory PathRegulatory requirements compared

Active substances

Estradiol + Levonorgestrel

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CLIMARA PRO0.045MG/24HR;0.015MG/24HRfilm, extended release · transdermalBAYER HLTHCAREPrescription21 Nov 2003
CLIMARA PRO0.045MGsystem · transdermalBERLEX LABSPrescription27 Dec 2005

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
FEMSEVEN CONTI 50 MICROGRAMS/7 MICROGRAMS/24 HOURS, TRANSDERMAL PATCHPL 49876/0010THERAMEX IRELAND LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLIMARA PRO PATCH$59.6446per EA23 Sep 2026
NHS Drug TariffEstradiol 50micrograms/24hours / Levonorgestrel 7micrograms/24hours transdermal patches£15.484 patch1 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.

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.