PMDA drug package insert
エスゾピクロン錠1mg「ケミファ」
PMDA Prescription drug · 日本ケミファ株式会社 · package insert Mar 12, 2024
Key facts
| Brand names | エスゾピクロン錠1mg「ケミファ」, エスゾピクロン錠2mg「ケミファ」, エスゾピクロン錠3mg「ケミファ」 |
|---|---|
| Nonproprietary names | エスゾピクロン |
| Companies | 製造販売元／日本ケミファ株式会社, 販売元／日本薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 不眠症治療薬 |
| Therapeutic category codes | 871129 |
| YJ codes | 1129010F1109, 1129010F2105, 1129010F3101 |
| Approval numbers | 30300AMX00091000, 30300AMX00092000, 30300AMX00093000 |
| Package insert edition | 第1版 |
| Package insert date | Mar 12, 2024 |
| PMDA document key | 530213_1129010F1109_2 |
| PMDA company code | 530213 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- No 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: