PMDA drug package insert
タダラフィル錠2.5mgZA「シオエ」
PMDA Prescription drug · シオエ製薬株式会社 · package insert Nov 13, 2024
Key facts
| Brand names | タダラフィル錠2.5mgZA「シオエ」, タダラフィル錠5mgZA「シオエ」 |
|---|---|
| Nonproprietary names | タダラフィル |
| Companies | 製造販売元／シオエ製薬株式会社, 販売／日本新薬株式会社 |
| 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 | 2590016F1110, 2590016F2116 |
| Approval numbers | 30300AMX00400000, 30300AMX00401000 |
| Package insert edition | 第4版 |
| Package insert date | Nov 13, 2024 |
| PMDA document key | 340013_2590016F1110_1 |
| PMDA company code | 340013 |
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: