PMDA drug package insert
ブコラム口腔用液2.5mg
PMDA Prescription drug · クリニジェン株式会社 · package insert May 20, 2026
Key facts
| Brand names | ブコラム口腔用液2.5mg, ブコラム口腔用液5mg, ブコラム口腔用液7.5mg, ブコラム口腔用液10mg |
|---|---|
| Nonproprietary names | ミダゾラム |
| Companies | 製造販売元／クリニジェン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗けいれん剤 |
| Therapeutic category codes | 871139 |
| YJ codes | 1139700Q1029, 1139700Q2025, 1139700Q3021, 1139700Q4028 |
| Approval numbers | 30200AMX00935, 30200AMX00936, 30200AMX00937, 30200AMX00938 |
| Package insert edition | 第4版 |
| Package insert date | May 20, 2026 |
| PMDA document key | 850372_1139700Q1029_2 |
| PMDA company code | 850372 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: