PMDA drug package insert
ロナセン錠2mg
PMDA Prescription drug · 住友ファーマ株式会社 · package insert Aug 3, 2026
Key facts
| Brand names | ロナセン錠2mg, ロナセン錠4mg, ロナセン錠8mg, ロナセン散2％ |
|---|---|
| Nonproprietary names | ブロナンセリン |
| Companies | 製造販売元／住友ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179048F1027, 1179048F2023, 1179048F3020, 1179048B1025 |
| Approval numbers | 22000AMX00011, 22000AMX00012, 22100AMX02285, 22000AMX00013 |
| Package insert edition | 第12版 |
| Package insert date | Aug 3, 2026 |
| PMDA document key | 400093_1179048B1025_1 |
| PMDA company code | 400093 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: