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Multifunctional serotonin agonist/antagonist (HSDD)

Flibanserin in Japan: prescription, brands, pricing

This page summarises the situation of Flibanserin in Japan under PMDA (Pharmaceuticals and Medical Devices Agency): prescription status, available brands and generics, pharmacy dispensing, and online options in JPY. Flibanserin belongs to the Multifunctional serotonin agonist/antagonist (HSDD) class.

Regulator
PMDA (Pharmaceuticals and Medical Devices Agency)
Currency
JPY

About Flibanserin

Flibanserin is approved by the FDA for hypoactive sexual desire disorder (HSDD) in premenopausal women — specifically, acquired (not lifelong) and generalised (not situational) HSDD, with personal distress, not better explained by another c… 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

Flibanserin acts as a serotonin 5-HT1A receptor agonist and 5-HT2A receptor antagonist, with additional effects on dopamine and norepinephrine signalling.

Brands and generics in Japan

In Japan, Flibanserin 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 Flibanserin 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 Flibanserin available in Japan?

Yes — Flibanserin 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 Flibanserin 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 Flibanserin (Rx or OTC) is determined by PMDA (Pharmaceuticals and Medical Devices Agency); most active ingredients in the Multifunctional serotonin agonist/antagonist (HSDD) class require prescription, although there are exceptions by country and formulation.

How much does Flibanserin 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 Flibanserin in Japan

Flibanserin 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.