PMDA drug package insert

ビオチン注1mg「フソー」

PMDA Prescription drug · 扶桑薬品工業株式会社 · package insert Oct 1, 2026

Key facts

Brand names ビオチン注1mg「フソー」
Nonproprietary names ビオチン
Companies 製造販売元/扶桑薬品工業株式会社
Product type Prescription drug
Therapeutic category ビタミンH製剤
Therapeutic category codes 87319
YJ codes 3190400A1036
Approval numbers 21800AMX10535
Package insert edition 第3版
Package insert date Oct 1, 2026
PMDA document key 670156_3190400A1036_1
PMDA company code 670156

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)