PMDA drug package insert

本草八味地黄丸料エキス顆粒-H

PMDA OTC drug · 新大和漢方(株) · package insert May 7, 2021

Key facts

Brand names 本草八味地黄丸料エキス顆粒-H
Companies 製造販売元/本草製薬(株),販売会社/新大和漢方(株)
Product type OTC drug
OTC risk class 第2類医薬品
OTC dosage form 散剤
OTC effect category 八味地黄丸(腎気丸,八味腎気丸,崔氏八味丸), 漢方製剤
Package insert date May 7, 2021
PMDA document key 710082_J2101000047
PMDA company code 710082

At a glance

  • 1–9 Package insert revisions
  • None 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)