PMDA drug package insert
マイスリー錠5mg
PMDA Prescription drug · アステラス製薬株式会社 · package insert Jun 19, 2023
Key facts
| Brand names | マイスリー錠5mg, マイスリー錠10mg |
|---|---|
| Nonproprietary names | ゾルピデム酒石酸塩 |
| Companies | 製造販売／アステラス製薬株式会社, 販売提携／サノフィ株式会社, 提携／sanofi |
| Product type | Prescription drug |
| Therapeutic category | 入眠剤 |
| Therapeutic category codes | 871129 |
| YJ codes | 1129009F1025, 1129009F2021 |
| Approval numbers | 21200AMZ00560, 21200AMZ00561 |
| Package insert edition | 第2版 |
| Package insert date | Jun 19, 2023 |
| PMDA document key | 800126_1129009F1025_3 |
| PMDA company code | 800126 |
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: