PMDA drug package insert
タルセバ錠25mg
PMDA Prescription drug · チェプラファーム株式会社 · package insert Apr 1, 2025
Key facts
| Brand names | タルセバ錠25mg, タルセバ錠100mg |
|---|---|
| Nonproprietary names | エルロチニブ塩酸塩 |
| Companies | 製造販売元／チェプラファーム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤; 上皮増殖因子受容体（EGFR）チロシンキナーゼ阻害剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291016F1020, 4291016F2027 |
| Approval numbers | 21900AMX01758, 21900AMX01759 |
| Package insert edition | 第6版 |
| Package insert date | Apr 1, 2025 |
| PMDA document key | 450900_4291016F1020_2 |
| PMDA company code | 450900 |
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: