PMDA drug package insert
シロドシン錠2mg「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Feb 6, 2026
Key facts
| Brand names | シロドシン錠2mg「DSEP」, シロドシン錠4mg「DSEP」, シロドシンOD錠2mg「DSEP」, シロドシンOD錠4mg「DSEP」 |
|---|---|
| Nonproprietary names | シロドシン |
| Companies | 製造販売元／第一三共エスファ株式会社, 販売提携／第一三共株式会社, 技術提携／キッセイ薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的α1A遮断薬/前立腺肥大症に伴う排尿障害改善薬 |
| Therapeutic category codes | 87259 |
| YJ codes | 2590010F1031, 2590010F2038, 2590010F3034, 2590010F4030 |
| Approval numbers | 23000AMX00769, 23000AMX00770, 23000AMX00771, 23000AMX00772 |
| Package insert edition | 第3版 |
| Package insert date | Feb 6, 2026 |
| PMDA document key | 430773_2590010F1031_1 |
| PMDA company code | 430773 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: