PMDA drug package insert
ブスルフェクス点滴静注用60mg
PMDA Prescription drug · 大塚製薬株式会社 · package insert Aug 21, 2023
Key facts
| Brand names | ブスルフェクス点滴静注用60mg |
|---|---|
| Nonproprietary names | ブスルファン |
| Companies | 製造販売元／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 造血幹細胞移植前治療薬 |
| Therapeutic category codes | 874213 |
| YJ codes | 4213400A2025 |
| Approval numbers | 21800AMY10108 |
| Package insert edition | 第4版 |
| Package insert date | Aug 21, 2023 |
| PMDA document key | 180078_4213400A2025_4 |
| PMDA company code | 180078 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: