PMDA drug package insert
ニトラゼパム錠5mg「NIG」
PMDA Prescription drug · 日医工岐阜工場株式会社 · package insert Feb 1, 2026
Key facts
| Brand names | ニトラゼパム錠5mg「NIG」 |
|---|---|
| Nonproprietary names | ニトラゼパム |
| Companies | 製造販売元／日医工岐阜工場株式会社, 販売元／日医工株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 睡眠誘導剤、抗痙攣剤 |
| Therapeutic category codes | 871124, 871139 |
| YJ codes | 1124003F2311 |
| Approval numbers | 22500AMX01282 |
| Package insert edition | 第2版 |
| Package insert date | Feb 1, 2026 |
| PMDA document key | 581120_1124003F2311_1 |
| PMDA company code | 581120 |
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: