PMDA drug package insert
ハロマンス注50mg
PMDA Prescription drug · クリニジェン株式会社 · package insert Nov 28, 2025
Key facts
| Brand names | ハロマンス注50mg, ハロマンス注100mg |
|---|---|
| Nonproprietary names | ハロペリドールデカン酸エステル |
| Companies | 製造販売元／クリニジェン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持効性抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179406A1037, 1179406A2033 |
| Approval numbers | 16200AMZ00997000, 16200AMZ00998000 |
| Package insert edition | 第5版 |
| Package insert date | Nov 28, 2025 |
| PMDA document key | 850372_1179406A1037_3 |
| PMDA company code | 850372 |
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: