Regulatory PathRegulatory requirements compared

Active substance

Tamoxifen

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Farshias10 mgFilm-coated tablet · Oral use30 BlisterSAR 22.20Generic · PrescriptionEugia Pharma Specialities LimitedValid
NOLVADEX 10 MG TABs10 mgTablet · Oral use30 BlisterSAR 37.80NCE · PrescriptionAstraZenecaValid
NOLVADEX-D TAB 20MG20 mgTablet · Oral use30 BlisterSAR 65.80Generic · PrescriptionAstraZenecaValid
NOLVADEX 10 MG TABs10 mgTablet · Oral use250 Tablet ContainerSAR 242.50NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
TAMOFEN 10MG TAB10 mgTablet · Oral use100 Tablet ContainerSAR 117.90Generic · PrescriptionBAYER OYWithdrawn by MAH · Not Marketed
TAMOFEN 10MG TAB10 mgTablet · Oral use30 BlisterSAR 24.75Generic · PrescriptionBAYER OYWithdrawn by MAH · Not Marketed
TAMOFEN 20MG TAB20 mgTablet · Oral use100 Tablet ContainerSAR 175.05Generic · PrescriptionBAYER SCHERING PHARMAWithdrawn by MAH · Not Marketed
TAMOFEN 20MG TAB20 mgTablet · Oral use30 BlisterSAR 56.20Generic · PrescriptionBAYER SCHERING PHARMAWithdrawn by MAH · Not Marketed
TAMOPHAR 10 MG TABLET10 mgTablet · Oral use30 BlisterSAR 24.75Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
TAMOPLEX 10MG-TAB.10 mgTablet · Oral use30 BlisterSAR 28.00Generic · PrescriptionPHARMACHEMIEWithdrawn by regulatory authority · Not Marketed
TAMOXIFEN 10MG EBEWE10 mgFilm-coated tablet · Oral use30 BlisterSAR 24.20Generic · PrescriptionEBEWE PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE MANIA; BREAST CANCER EARLY HORMONAL; BREAST CANCER MET.HORMONAL; ENDOMETRIAL CANCER; OVARIAN CANCER

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

ProductStrengthForm · routeApplicantStatusFirst approved
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralACTAVIS LABS FL INCPrescription20 Feb 2003
TAMOXIFEN CITRATEEQ 20MG BASE; EQ 10MG BASEtablet · oralMYLANPrescription20 Feb 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralDR REDDYS LABS SAPrescription20 Feb 2003
SOLTAMOXEQ 20MG BASE/10MLsolution · oralMAYNE PHARMA COMMRCLPrescription29 Oct 2005
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralZYDUS PHARMSPrescription27 Oct 2017
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralEUGIA PHARMAPrescription14 Aug 2020
NOLVADEXEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralASTRAZENECADiscontinued30 Dec 1977
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralIVAX SUB TEVA PHARMSDiscontinued20 Feb 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralROXANEDiscontinued20 Feb 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralACTAVIS LABS FL INCDiscontinued20 Feb 2003
TAMOXIFEN CITRATEEQ 10MG BASEtablet · oralPHARMACHEMIEDiscontinued31 Mar 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralAEGIS PHARMSDiscontinued31 Mar 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralTEVADiscontinued28 Apr 2003
TAMOXIFEN CITRATEEQ 10MG BASE; EQ 20MG BASEtablet · oralAPOTEXDiscontinued23 Sep 2011

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-TAMOX TAB 10MG0081240410 MGTABLET · ORALAPOTEX INC
APO-TAMOX TAB 20MG0081239020 MGTABLET · ORALAPOTEX INC
TEVA-TAMOXIFEN0085196510 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-TAMOXIFEN0085197320 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACTAMOXIFEN 10 MG TABLET$0.12555per EA23 Sep 2026
US NADACTAMOXIFEN 20 MG TABLET$0.27682per EA23 Sep 2026
NHS Drug TariffTamoxifen 10mg tablets£3.8230 tablet1 Oct 2026
NHS Drug TariffTamoxifen 10mg/5ml oral solution sugar free£125.56150 ml1 Oct 2026
NHS Drug TariffTamoxifen 20mg tablets£2.5930 tablet1 Oct 2026
NHS Drug TariffTamoxifen 40mg tablets£98.9330 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)

  • 8.2.4. Hormones and antihormones · complementary
    Malignant neoplasms of breast; Other specified malignant neoplasms of breast
    Oral > Solid: 10 mg (as citrate); 20 mg (as citrate)

Safety signals and safety-related labeling changes

  • US FDA 25 Sep 2018 SOLTAMOX — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tamoxifen →

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.