PMDA drug package insert
ブロナンセリン錠2mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Mar 17, 2026
Key facts
| Brand names | ブロナンセリン錠2mg「アメル」, ブロナンセリン錠4mg「アメル」, ブロナンセリン錠8mg「アメル」, ブロナンセリン散2%「アメル」 |
|---|---|
| Nonproprietary names | ブロナンセリン |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179048F1078, 1179048F2074, 1179048F3070, 1179048B1041 |
| Approval numbers | 23100AMX00243, 23100AMX00244, 23100AMX00245, 23100AMX00239 |
| Package insert edition | 第4版 |
| Package insert date | Mar 17, 2026 |
| PMDA document key | 672173_1179048B1041_3 |
| 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
- Yes 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: