PMDA drug package insert
ブーレンレップ点滴静注用70mg
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Oct 2, 2026
Key facts
| Brand names | ブーレンレップ点滴静注用70mg, ブーレンレップ点滴静注用100mg |
|---|---|
| Nonproprietary names | ベランタマブ マホドチン（遺伝子組換え） |
| Companies | 製造販売元／グラクソ・スミスクライン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; 微小管阻害薬結合ヒト化抗BCMAモノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291484D2025, 4291484D1029 |
| Approval numbers | 30800AMX00068, 30700AMX00089 |
| Package insert edition | 第3版 |
| Package insert date | Oct 2, 2026 |
| PMDA document key | 340278_4291484D1029_1 |
| PMDA company code | 340278 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: