PMDA drug package insert
リボトリール錠0.5mg
PMDA Prescription drug · 太陽ファルマ株式会社 · package insert Aug 25, 2023
Key facts
| Brand names | リボトリール錠0.5mg, リボトリール錠1mg, リボトリール錠2mg, リボトリール細粒0.1%, リボトリール細粒0.5% |
|---|---|
| Nonproprietary names | クロナゼパム |
| Companies | 製造販売元／太陽ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗てんかん剤 |
| Therapeutic category codes | 871139 |
| YJ codes | 1139003F1040, 1139003F2047, 1139003F3043, 1139003C1044, 1139003C2040 |
| Approval numbers | 21800AMX10254, 21800AMX10255, 21800AMX10256, 21800AMX10253, 21800AMX10292 |
| Package insert edition | 第1版 |
| Package insert date | Aug 25, 2023 |
| PMDA document key | 431010_1139003C1044_2 |
| PMDA company code | 431010 |
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: