PMDA drug package insert
ザイティガ錠250mg
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Oct 31, 2023
Key facts
| Brand names | ザイティガ錠250mg, ザイティガ錠500mg |
|---|---|
| Nonproprietary names | アビラテロン酢酸エステル |
| Companies | 製造販売元／ヤンセンファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 前立腺癌治療剤（CYP17阻害剤） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291033F1024, 4291033F2020 |
| Approval numbers | 22600AMX00749000, 30500AMX00013000 |
| Package insert edition | 第4版 |
| Package insert date | Oct 31, 2023 |
| PMDA document key | 800155_4291033F1024_1 |
| PMDA company code | 800155 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- Yes 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: