PMDA drug package insert
八味地黄丸
PMDA OTC drug · 三井薬品株式会社 · package insert May 13, 2026
Key facts
| Brand names | 八味地黄丸 |
|---|---|
| Companies | 製造販売元／二反田薬品工業株式会社,販売会社／三井薬品株式会社 |
| 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 | May 13, 2026 |
| PMDA document key | 530048_K2605000004 |
| PMDA company code | 530048 |
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: