PMDA drug package insert
タダラフィル錠2.5mgZA「フソー」
PMDA Prescription drug · シオノケミカル株式会社 · package insert Oct 1, 2026
Key facts
| Brand names | タダラフィル錠2.5mgZA「フソー」, タダラフィル錠5mgZA「フソー」 |
|---|---|
| Nonproprietary names | タダラフィル |
| Companies | 製造販売（輸入）元／シオノケミカル株式会社, 販売元／扶桑薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 前立腺肥大症に伴う排尿障害改善剤 （ホスホジエステラーゼ5阻害剤） |
| Therapeutic category codes | 87259 |
| YJ codes | 2590016F1101, 2590016F2108 |
| Approval numbers | 30200AMX00069000, 30200AMX00070000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 1, 2026 |
| PMDA document key | 340409_2590016F1101_1 |
| PMDA company code | 340409 |
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: