PMDA drug package insert
ロペミンカプセル1mg
PMDA Prescription drug · 帝國製薬株式会社 · package insert Nov 14, 2025
Key facts
| Brand names | ロペミンカプセル1mg, ロペミン細粒0.1% |
|---|---|
| Nonproprietary names | ロペラミド塩酸塩 |
| Companies | 製造販売元／帝國製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 止瀉剤 |
| Therapeutic category codes | 872319 |
| YJ codes | 2319001M1213, 2319001C2060 |
| Approval numbers | 21800AMX10315000, 21800AMX10286000 |
| Package insert edition | 第3版 |
| Package insert date | Nov 14, 2025 |
| PMDA document key | 470006_2319001C2060_2 |
| PMDA company code | 470006 |
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: