PMDA drug package insert
クービビック錠25mg
PMDA Prescription drug · ネクセラファーマジャパン株式会社 · package insert Oct 13, 2026
Key facts
| Brand names | クービビック錠25mg, クービビック錠50mg |
|---|---|
| Nonproprietary names | ダリドレキサント塩酸塩 |
| Companies | 製造販売元／ネクセラファーマジャパン株式会社, 販売元／塩野義製薬株式会社 |
| 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 | 1190033F1028, 1190033F2024 |
| Approval numbers | 30600AMX00253000, 30600AMX00254000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 13, 2026 |
| PMDA document key | 150923_1190033F1028_1 |
| PMDA company code | 150923 |
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: