PMDA drug package insert
オランザピンOD錠1.25mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Aug 25, 2026
Key facts
| Brand names | オランザピンOD錠1.25mg「アメル」, オランザピンOD錠2.5mg「アメル」, オランザピンOD錠5mg「アメル」, オランザピンOD錠10mg「アメル」 |
|---|---|
| Nonproprietary names | オランザピン |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病薬・双極性障害治療薬・制吐剤 |
| Therapeutic category codes | 871179, 872391 |
| YJ codes | 1179044F9020, 1179044F6063, 1179044F4060, 1179044F5067 |
| Approval numbers | 22800AMX00067, 22800AMX00068, 22800AMX00069, 22800AMX00070 |
| Package insert edition | 第3版 |
| Package insert date | Aug 25, 2026 |
| PMDA document key | 672173_1179044F4060_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: