PMDA drug package insert
ルパフィン錠10mg
PMDA Prescription drug · 帝國製薬株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | ルパフィン錠10mg |
|---|---|
| Nonproprietary names | ルパタジンフマル酸塩 |
| Companies | 製造販売元／帝國製薬株式会社, 販売元／田辺ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | アレルギー性疾患治療剤 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490034F1022 |
| Approval numbers | 22900AMX00962 |
| Package insert edition | 第3版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 470006_4490034F1022_1 |
| PMDA company code | 470006 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: