PMDA drug package insert
トラスツズマブBS点滴静注用60mg「ファイザー」
PMDA Prescription drug · ファイザー株式会社 · package insert Jun 26, 2026
Key facts
| Brand names | トラスツズマブBS点滴静注用60mg「ファイザー」, トラスツズマブBS点滴静注用150mg「ファイザー」 |
|---|---|
| Nonproprietary names | トラスツズマブ（遺伝子組換え） |
| Companies | 製造販売／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗HER2ヒト化モノクローナル抗体 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 | 4291447D1028, 4291447D2024 |
| Approval numbers | 23000AMX00800, 23000AMX00801 |
| Package insert edition | 第4版 |
| Package insert date | Jun 26, 2026 |
| PMDA document key | 672212_4291447D1028_2 |
| PMDA company code | 672212 |
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: