EVISTA

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

Active ingredients

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

1
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 more about Raloxifene

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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

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