PMDA drug package insert
ルネスタ錠1mg
PMDA Prescription drug · エーザイ株式会社 · package insert Dec 16, 2024
Key facts
| Brand names | ルネスタ錠1mg, ルネスタ錠2mg, ルネスタ錠3mg |
|---|---|
| Nonproprietary names | エスゾピクロン |
| Companies | 製造販売元／エーザイ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 不眠症治療薬 |
| Therapeutic category codes | 871129 |
| YJ codes | 1129010F1028, 1129010F2024, 1129010F3020 |
| Approval numbers | 22400AMX00027000, 22400AMX00028000, 22400AMX00029000 |
| Package insert edition | 第2版 |
| Package insert date | Dec 16, 2024 |
| PMDA document key | 170033_1129010F1028_1 |
| PMDA company code | 170033 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: