PMDA drug package insert

JPS八味地黄丸料エキス錠N

PMDA OTC drug · ジェーピーエス製薬(株) · package insert Sep 28, 2021

Key facts

Brand names JPS八味地黄丸料エキス錠N
Companies 製造販売元/ジェーピーエス製薬(株),販売会社/ジェーピーエス製薬(株),販売会社/ジェーピーエス製薬(株)
Product type OTC drug
OTC risk class 第2類医薬品
OTC dosage form 錠剤
OTC effect category 八味地黄丸(腎気丸,八味腎気丸,崔氏八味丸)
Package insert date Sep 28, 2021
PMDA document key 340008_J0601010345
PMDA company code 340008

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:

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