PMDA drug package insert
ビカルタミド錠80mg「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Jan 9, 2026
Key facts
| Brand names | ビカルタミド錠80mg「DSEP」, ビカルタミドOD錠80mg「DSEP」 |
|---|---|
| Nonproprietary names | ビカルタミド |
| 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 |
| Product type | Prescription drug |
| Therapeutic category | 前立腺癌治療剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291009F1276, 4291009F2124 |
| Approval numbers | 23100AMX00208, 23100AMX00209 |
| Package insert edition | 第2版 |
| Package insert date | Jan 9, 2026 |
| PMDA document key | 430773_4291009F1276_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: