EVISTA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

Active ingredients

The drug EVISTA contains one active pharmaceutical ingredient (API):

1 Raloxifene
UNII 4F86W47BR6 - RALOXIFENE HYDROCHLORIDE

As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen. It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.

Read about Raloxifene

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
EVISTA Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR
EVISTA Film-coated tablet European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
G03XC01 Raloxifene G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03X Other sex hormones and modulators of the genital system → G03XC Selective estrogen receptor modulators
Discover more medicines within G03XC01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 8363E
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 507601201115215, 507601202111213, 507601204114317
Country: CA Health Products and Food Branch Identifier(s): 02239028
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 2515-MEE-0117
Country: EE Ravimiamet Identifier(s): 1038394, 1064135, 1209710, 1209721
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 98073002
Country: FR Base de données publique des médicaments Identifier(s): 67365141
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 199994
Country: HK Department of Health Drug Office Identifier(s): 44728
Country: IE Health Products Regulatory Authority Identifier(s): 24432, 24527, 24552, 24564, 24592, 24607
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 3618
Country: IT Agenzia del Farmaco Identifier(s): 034153015, 034153027
Country: JP 医薬品医療機器総合機構 Identifier(s): 3999021F1023
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1003008, 1028049, 1028050, 1028051
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 586M97
Country: NL Z-Index G-Standaard, PRK Identifier(s): 50881
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 7175
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100089480
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W53455001, W53455002, W53455003, W53455004
Country: SG Health Sciences Authority Identifier(s): 10872P
Country: US FDA, National Drug Code Identifier(s): 0002-4184
Country: ZA Health Products Regulatory Authority Identifier(s): 32/34/0422

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