PMDA drug package insert
ベルソムラ錠10mg
PMDA Prescription drug · MSD株式会社 · package insert Aug 25, 2026
Key facts
| Brand names | ベルソムラ錠10mg, ベルソムラ錠15mg, ベルソムラ錠20mg |
|---|---|
| Nonproprietary names | スボレキサント |
| Companies | 製造販売元／MSD株式会社, 販売元／第一三共株式会社 |
| 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 | 1190023F3027, 1190023F1024, 1190023F2020 |
| Approval numbers | 22800AMX00671000, 22600AMX01302000, 22600AMX01303000 |
| Package insert edition | 第6版 |
| Package insert date | Aug 25, 2026 |
| PMDA document key | 170050_1190023F1024_1 |
| PMDA company code | 170050 |
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: