Is Toremifene registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Toremifene, including Sermitor (60 mg, Tablet, SAR 155.05).

Is Toremifene approved by the US FDA?

Drugs@FDA lists 3 application product lines for Toremifene, including TOREMIFENE CITRATE (Prescription); TOREMIFENE CITRATE (Prescription); FARESTON (Discontinued).

Is Toremifene authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Toremifene: Fareston.

Are there safety signals or safety updates for Toremifene?

US FDA: 1 entry; MHRA: 1 entry (latest 2024-12-13).

Active substance

Toremifene

SFDA 1
US FDA 3
EMA 1
US price lines 1
NHS prices 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Sermitor	60 mg	Tablet · Oral use	30 Blister	SAR 155.05	Generic · Prescription	Boston Oncology Arabia	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL

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

Product	Strength	Form · route	Applicant	Status	First approved
TOREMIFENE CITRATE	EQ 60MG BASE	tablet · oral	RISING	Prescription	4 Dec 2018
TOREMIFENE CITRATE	EQ 60MG BASE	tablet · oral	MSN	Prescription	18 Aug 2020
FARESTON	EQ 60MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	KYOWA KIRIN	Discontinued	29 May 1997

EMA European Union — centrally authorised medicines

Fareston Orion Corporation · Authorised · authorised 14 Feb 1996 · ATC L02BA02

Therapeutic indication (EMA)

First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TOREMIFENE CITRATE 60 MG TAB	$19.59893	per EA	23 Sep 2026
NHS Drug Tariff	Toremifene 60mg tablets	£29.08	30 tablet	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.

Safety signals and safety-related labeling changes

US FDA 13 Dec 2024 FARESTON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Toremifene (Fareston): risk of QT prolongation
Toremifene (fareston) is associated with a dose-dependent risk of QT prolongation.

All safety entries for toremifene →

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.