Selective estrogen receptor modulator (SERM)
Raloxifene in Japan: prescription, brands, pricing
This page summarises the situation of Raloxifene in Japan under PMDA (Pharmaceuticals and Medical Devices Agency): prescription status, available brands and generics, pharmacy dispensing, and online options in JPY. Raloxifene belongs to the Selective estrogen receptor modulator (SERM) class.
- Regulator
- PMDA (Pharmaceuticals and Medical Devices Agency)
- Currency
- JPY
About Raloxifene
Raloxifene is approved for prevention and treatment of postmenopausal osteoporosis, and for reduction of invasive breast cancer risk in postmenopausal women at increased risk. Japan classifies medicines into prescription drugs (医療用医薬品) and OTC drugs (一般用医薬品), the latter further divided into pharmacist-only (第1類) and self-service classes. The Ministry of Health, Labour and Welfare (MHLW) sets the regulatory framework; PMDA reviews safety and efficacy.
Mechanism and action
Raloxifene binds estrogen receptors and produces tissue-selective effects: estrogen-agonist activity in bone (preserving bone mineral density) and on lipid metabolism (lowering LDL cholesterol), while exhibiting estrogen-antagonist activity…
Brands and generics in Japan
In Japan, Raloxifene is typically dispensed as one internationally recognised brand along with their corresponding authorised generics. Japanese pharmacies (薬局) and drugstores (ドラッグストア) such as Matsumoto Kiyoshi and Welcia are widespread. Prescription dispensing pharmacies (調剤薬局) are usually located near hospitals and clinics; pharmacist counselling at dispensing is mandated by the Pharmaceutical Affairs Law. Brand-to-generic substitution is decided by the pharmacist under local PMDA (Pharmaceuticals and Medical Devices Agency) equivalence rules, and the price difference in JPY is usually substantial.
Online and tele-prescribing access
Japan permits online sale of most OTC medicines under the 2014 amendments to the Pharmaceutical Affairs Law, with class-based restrictions. Online prescription dispensing is allowed via licensed pharmacies after a face-to-face or telemedicine consultation; personal importation of prescription medication is restricted to limited quantities for personal use. For Raloxifene specifically, the legal online options in Japan depend on its Rx-or-OTC classification under PMDA (Pharmaceuticals and Medical Devices Agency).
Frequently asked questions
Is Raloxifene available in Japan? ▾
Yes — Raloxifene and its brands are available in Japan through pharmacies authorised by PMDA (Pharmaceuticals and Medical Devices Agency), in various strengths depending on the commercial product. Authorised generics offer a lower-cost alternative with the same active substance.
Do I need a prescription for Raloxifene in Japan? ▾
Japan classifies medicines into prescription drugs (医療用医薬品) and OTC drugs (一般用医薬品), the latter further divided into pharmacist-only (第1類) and self-service classes. The Ministry of Health, Labour and Welfare (MHLW) sets the regulatory framework; PMDA reviews safety and efficacy. The exact status of Raloxifene (Rx or OTC) is determined by PMDA (Pharmaceuticals and Medical Devices Agency); most active ingredients in the Selective estrogen receptor modulator (SERM) class require prescription, although there are exceptions by country and formulation.
How much does Raloxifene cost in Japan? ▾
The price in JPY depends on the manufacturer (brand vs authorised generic), the strength and the pack size. Generics are typically substantially cheaper than brands and serve as the economic reference for ongoing use.
Products with Raloxifene in Japan
Raloxifene in other countries
The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.