PMDA drug package insert
サイレース錠1mg
PMDA Prescription drug · エーザイ株式会社 · package insert Apr 20, 2023
Key facts
| Brand names | サイレース錠1mg, サイレース錠2mg |
|---|---|
| Nonproprietary names | フルニトラゼパム |
| 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 | 871124 |
| YJ codes | 1124008F1024, 1124008F2020 |
| Approval numbers | 15800AMZ00620000, 15800AMZ00621000 |
| Package insert edition | 第1版 |
| Package insert date | Apr 20, 2023 |
| PMDA document key | 170033_1124008F1024_1 |
| PMDA company code | 170033 |
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: