PMDA drug package insert
ハロペリドール錠0.75mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Feb 27, 2025
Key facts
| Brand names | ハロペリドール錠0.75mg「アメル」, ハロペリドール錠1mg「アメル」, ハロペリドール錠1.5mg「アメル」, ハロペリドール錠2mg「アメル」, ハロペリドール錠3mg「アメル」, ハロペリドール細粒1%「アメル」 |
|---|---|
| Nonproprietary names | ハロペリドール |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179020F1244, 1179020F2100, 1179020F3298, 1179020F4073, 1179020F5142, 1179020C1280 |
| Approval numbers | 22500AMX01012, 22500AMX01015, 22500AMX01013, 22500AMX01014, 22500AMX01017, 22500AMX01011 |
| Package insert edition | 第4版 |
| Package insert date | Feb 27, 2025 |
| PMDA document key | 672173_1179020C1280_2 |
| PMDA company code | 672173 |
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: