PMDA drug package insert
エビリファイOD錠3mg
PMDA Prescription drug · 大塚製薬株式会社 · package insert Dec 15, 2025
Key facts
| Brand names | エビリファイOD錠3mg, エビリファイOD錠6mg, エビリファイOD錠12mg, エビリファイOD錠24mg |
|---|---|
| Nonproprietary names | アリピプラゾール |
| Companies | 製造販売元／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病薬 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179045F4022, 1179045F5029, 1179045F6025, 1179045F7021 |
| Approval numbers | 22400AMX00030, 22400AMX00031, 22400AMX00032, 22400AMX00033 |
| Package insert edition | 第6版 |
| Package insert date | Dec 15, 2025 |
| PMDA document key | 180078_1179045F4022_1 |
| PMDA company code | 180078 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None 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: