PMDA drug package insert
ベンダムスチン塩酸塩点滴静注液25mg/1mL「イセイ」
PMDA Prescription drug · コーアイセイ株式会社 · package insert Sep 24, 2025
Key facts
| Brand names | ベンダムスチン塩酸塩点滴静注液25mg/1mL「イセイ」, ベンダムスチン塩酸塩点滴静注液100mg/4mL「イセイ」 |
|---|---|
| Nonproprietary names | ベンダムスチン塩酸塩 |
| Companies | 製造販売元／コーアイセイ株式会社, 販売元／高田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 |
| Therapeutic category codes | 874219 |
| YJ codes | 4219405A2048, 4219405A1050 |
| Approval numbers | 30400AMX00103000, 30400AMX00104000 |
| Package insert edition | 第2版 |
| Package insert date | Sep 24, 2025 |
| PMDA document key | 130107_4219405A2048_1 |
| PMDA company code | 130107 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None 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: