Is Estradiol + Norethisterone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Estradiol + Norethisterone.

Is Estradiol + Norethisterone approved by the US FDA?

Drugs@FDA lists 13 application product lines for Estradiol + Norethisterone, including COMBIPATCH (Prescription); ACTIVELLA (Prescription); ACTIVELLA (Prescription); ESTRADIOL AND NORETHINDRONE ACETATE (Prescription); ESTRADIOL AND NORETHINDRONE ACETATE (Prescription).

Active substances

Estradiol + Norethisterone

SFDA 1
US FDA 13
Health Canada 4
US price lines 2
NHS prices 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ESTRACOMB TTS PATCHES		Cutaneous patch · Transdermal use	4 Box	SAR 56.50	Generic · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
COMBIPATCH	0.05MG/24HR;0.14MG/24HR; 0.05MG/24HR;0.25MG/24HR	film, extended release · transdermal	NOVEN PHARMS INC	Prescription	7 Aug 1998
ACTIVELLA	1MG;0.5MG	tablet · oral	AMNEAL	Prescription	18 Nov 1998
ACTIVELLA	1MG/0.5MG	tablet · oral	NOVO NORDISK INC	Prescription	29 Dec 2006
ESTRADIOL AND NORETHINDRONE ACETATE	1MG;0.5MG; 0.5MG;0.1MG	tablet · oral	BRECKENRIDGE PHARM	Prescription	17 Apr 2008
ESTRADIOL AND NORETHINDRONE ACETATE	1MG;0.5MG	tablet · oral	BARR	Prescription	11 May 2010
AMABELZ	0.5MG;0.1MG; 1MG;0.5MG	tablet · oral	LUPIN	Prescription	20 Jun 2016
ESTRADIOL AND NORETHINDRONE ACETATE	0.5MG;0.1MG; 1MG;0.5MG	tablet · oral	XIROMED	Prescription	10 Feb 2017
ESTRADIOL AND NORETHINDRONE ACETATE	1MG;0.5MG	tablet · oral	NAARI PTE	Prescription	28 Feb 2018
ESTRADIOL AND NORETHINDRONE ACETATE	0.5MG;0.1MG; 1MG;0.5MG	tablet · oral	NOVAST LABS	Prescription	3 Apr 2019
ACTIVELLA	0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	AMNEAL	Discontinued	18 Nov 1998
ACTIVELLA	1MG/0.5MG	tablet · oral	NOVO NORDISK	Discontinued	11 Apr 2000
ESTRADIOL AND NORETHINDRONE ACETATE	0.5MG;0.1MG	tablet · oral	TEVA PHARMS USA	Discontinued	8 Mar 2012
ETYQA	0.5MG;0.1MG; 1MG;0.5MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	30 Jun 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACTIVELLE	02249405	0.5 MG; 1 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
ACTIVELLE LD	02309009	0.5 MG; 0.1 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
ESTALIS 140/50 MCG	02241835	140 MCG / 24 HOUR; 50 MCG / 24 HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED
ESTALIS 250/50 MCG	02241837	250 MCG / 24 HOUR; 50 MCG / 24 HOUR	PATCH · TRANSDERMAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COMBIPATCH 0.05-0.14 MG PTCH	$31.83617	per EA	23 Sep 2026
US NADAC	COMBIPATCH 0.05-0.25 MG PTCH	$31.7862	per EA	23 Sep 2026
NHS Drug Tariff	Estradiol 1mg / Norethisterone acetate 500microgram tablets	£13.20	84 tablet	1 Oct 2026
NHS Drug Tariff	Estradiol 2mg / Norethisterone acetate 1mg tablets	£17.02	84 tablet	1 Oct 2026
NHS Drug Tariff	Estradiol 30micrograms/24hours / Norethisterone 95micrograms/24hours transdermal patches	£15.46	8 patch	1 Oct 2026
NHS Drug Tariff	Estradiol 30micrograms/24hours / Norethisterone 95micrograms/24hours transdermal patches	£44.27	24 patch	1 Oct 2026
NHS Drug Tariff	Estradiol 40micrograms/24hours / Norethisterone 130micrograms/24hours transdermal patches	£15.46	8 patch	1 Oct 2026
NHS Drug Tariff	Estradiol 40micrograms/24hours / Norethisterone 130micrograms/24hours transdermal patches	£44.27	24 patch	1 Oct 2026
NHS Drug Tariff	Estradiol 50micrograms/24hours / Norethisterone 170micrograms/24hours transdermal patches	£44.28	24 patch	1 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), 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.