Regulatory PathRegulatory requirements compared

Active substance

Raloxifene

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
EVISTA 60 MG F-C TABLETS60 mgFilm-coated tablet · Oral use28 BlisterSAR 88.55NCE · PrescriptionEli Lilly Nederland B.VValid
RALOSTA 60MG60 mgFilm-coated tablet · Oral use28 BlisterSAR 104.70Generic · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; OSTEOPOROSIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
EVISTA60MGtablet · oralLILLYPrescription9 Dec 1997
EVISTA60MGtablet · oralLILLYPrescription13 Sep 2007
RALOXIFENE HYDROCHLORIDE60MGtablet · oralTEVA PHARMS USAPrescription4 Mar 2014
RALOXIFENE HYDROCHLORIDE60MGtablet · oralINVAGEN PHARMSPrescription24 Sep 2014
RALOXIFENE HYDROCHLORIDE60MGtablet · oralWATSON LABS INCPrescription21 Jan 2015
RALOXIFENE HYDROCHLORIDE60MGtablet · oralAUROBINDO PHARMAPrescription28 Aug 2015
RALOXIFENE HYDROCHLORIDE60MGtablet · oralGLENMARK PHARMS LTDPrescription22 Mar 2016
RALOXIFENE HYDROCHLORIDE60MGtablet · oralAMNEAL PHARMSPrescription8 Apr 2016
RALOXIFENE HYDROCHLORIDE60MGtablet · oralSCIEGEN PHARMSPrescription12 Oct 2016
RALOXIFENE HYDROCHLORIDE60MGtablet · oralCADILA PHARMS LTDPrescription18 Aug 2020

EMA European Union — centrally authorised medicines

Evista Substipharm · Authorised · authorised 5 Aug 1998 · ATC G03XC01

Therapeutic indication (EMA)

Evista is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Evista or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Optruma Eli Lilly Nederland B.V. · Authorised · authorised 5 Aug 1998 · ATC G03XC01

Therapeutic indication (EMA)

Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Raloxifene Teva Teva B.V. · Authorised · authorised 29 Apr 2010 · ATC G03XC01

Therapeutic indication (EMA)

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ACT RALOXIFENE0235884060 MGTABLET · ORALTEVA CANADA LIMITED
APO-RALOXIFENE0227921560 MGTABLET · ORALAPOTEX INC
JAMP RALOXIFENE0254068160 MGTABLET · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACEVISTA 60 MG TABLET$6.34306per EA23 Sep 2026
US NADACRALOXIFENE HCL 60 MG TABLET$0.22348per EA23 Sep 2026
NHS Drug TariffRaloxifene 60mg tablets£5.0828 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.

Safety signals and safety-related labeling changes

  • US FDA 27 Jun 2018 EVISTA — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for raloxifene →

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.