PMDA drug package insert
サレドカプセル25
PMDA Prescription drug · 藤本製薬株式会社 · package insert May 7, 2025
Key facts
| Brand names | サレドカプセル25, サレドカプセル50, サレドカプセル100 |
|---|---|
| Nonproprietary names | サリドマイド |
| Companies | 製造販売元／藤本製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 多発性骨髄腫治療剤; らい性結節性紅斑治療剤; クロウ・深瀬（POEMS）症候群治療剤 |
| Therapeutic category codes | 874291, 876239, 87129 |
| YJ codes | 4291019M3026, 4291019M2020, 4291019M1023 |
| Approval numbers | 22600AMX00162000, 22100AMX00897000, 22000AMX02368000 |
| Package insert edition | 第5版 |
| Package insert date | May 7, 2025 |
| PMDA document key | 670142_4291019M1023_1 |
| PMDA company code | 670142 |
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: