PMDA drug package insert

コタロー八味丸料エキス細粒

PMDA Prescription drug · 小太郎漢方製薬株式会社 · package insert Jan 31, 2023

Key facts

Brand names コタロー八味丸料エキス細粒
Nonproprietary names 八味丸エキス
Companies 製造販売元/小太郎漢方製薬株式会社
Product type Prescription drug
Therapeutic category 漢方製剤
Therapeutic category codes 875200
YJ codes 5200120C1029
Approval numbers 16100AMZ03832000
Package insert edition 第1版
Package insert date Jan 31, 2023
PMDA document key 270127_5200120C1029_1
PMDA company code 270127

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)