PMDA drug package insert
スピロピタン錠0.25mg
PMDA Prescription drug · アルフレッサ ファーマ株式会社 · package insert Oct 28, 2024
Key facts
| Brand names | スピロピタン錠0.25mg, スピロピタン錠1mg |
|---|---|
| Nonproprietary names | スピペロン |
| Companies | 製造販売元／アルフレッサ ファーマ株式会社, 販売元／エーザイ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 統合失調症治療剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179015F1030, 1179015F2029 |
| Approval numbers | 21300AMZ00533000, 14600AMZ01104000 |
| Package insert edition | 第4版 |
| Package insert date | Oct 28, 2024 |
| PMDA document key | 530258_1179015F1030_3 |
| PMDA company code | 530258 |
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: