PMDA drug package insert
ヘルネクシオス錠60mg
PMDA Prescription drug · 日本ベーリンガーインゲルハイム株式会社 · package insert Nov 12, 2025
Key facts
| Brand names | ヘルネクシオス錠60mg |
|---|---|
| Nonproprietary names | ゾンゲルチニブ |
| Companies | 製造販売元／日本ベーリンガーインゲルハイム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤／HER2阻害剤 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）; ゾンゲルチニブ |
| Therapeutic category codes | 874291 |
| YJ codes | 4291096F1020 |
| Approval numbers | 30700AMX00225000 |
| Package insert edition | 第2版 |
| Package insert date | Nov 12, 2025 |
| PMDA document key | 650168_4291096F1020_1 |
| PMDA company code | 650168 |
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: