PMDA drug package insert
トラスツズマブBS点滴静注用60mg「NK」
PMDA Prescription drug · セルトリオン・ヘルスケア・ジャパン株式会社 · package insert Apr 18, 2025
Key facts
| Brand names | トラスツズマブBS点滴静注用60mg「NK」, トラスツズマブBS点滴静注用150mg「NK」 |
|---|---|
| Nonproprietary names | トラスツズマブ（遺伝子組換え） |
| Companies | 製造販売元／セルトリオン・ヘルスケア・ジャパン株式会社, 販売／日本化薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗HER2ヒト化モノクローナル抗体 抗悪性腫瘍剤; HER2：Human Epidermal Growth Factor Receptor Type 2 （ヒト上皮増殖因子受容体2型、別称：c-erbB-2） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291442D1033, 4291442D2030 |
| Approval numbers | 23000AMX00467, 23000AMX00468 |
| Package insert edition | 第4版 |
| Package insert date | Apr 18, 2025 |
| PMDA document key | 381103_4291442D1033_2 |
| PMDA company code | 381103 |
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: