Regulatory PathRegulatory requirements compared

Active substances

Estradiol + Medroxyprogesterone

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
LUNELLE5MG/0.5ML;25MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · intramuscularPHARMACIA AND UPJOHNDiscontinued5 Oct 2000

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
INDIVINA 1MG/2.5MG TABLETSPL 27925/0011ORION CORPORATIONPOM
INDIVINA 1MG/5MG TABLETSPL 27925/0012ORION CORPORATIONPOM
INDIVINA 2MG/5MG TABLETSPL 27925/0013ORION CORPORATIONPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffEstradiol valerate 1mg / Medroxyprogesterone 2.5mg tablets£20.5884 tablet1 Oct 2026
NHS Drug TariffEstradiol valerate 1mg / Medroxyprogesterone 5mg tablets£20.5884 tablet1 Oct 2026
NHS Drug TariffEstradiol valerate 2mg / Medroxyprogesterone 5mg tablets£20.5884 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)

  • 22.1.2. Injectable hormonal contraceptives · core
    Contact with health services for reasons associated with reproduction
    Parenteral > General injections > IM: 5 mg + 25 mg

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.