PMDA drug package insert
ボルズィ錠2.5mg
PMDA Prescription drug · 大正製薬株式会社 · package insert Nov 27, 2025
Key facts
| Brand names | ボルズィ錠2.5mg, ボルズィ錠5mg, ボルズィ錠10mg |
|---|---|
| Nonproprietary names | ボルノレキサント水和物 |
| Companies | 製造販売／大正製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | オレキシン受容体拮抗薬 不眠症治療薬 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190034F1022, 1190034F2029, 1190034F3025 |
| Approval numbers | 30700AMX00199000, 30700AMX00200000, 30700AMX00201000 |
| Package insert edition | 第2版 |
| Package insert date | Nov 27, 2025 |
| PMDA document key | 400059_1190034F1022_1 |
| PMDA company code | 400059 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: