PMDA drug package insert
テプミトコ錠250mg
PMDA Prescription drug · メルクバイオファーマ株式会社 · package insert Jan 24, 2025
Key facts
| Brand names | テプミトコ錠250mg |
|---|---|
| Nonproprietary names | テポチニブ塩酸塩水和物 |
| Companies | 製造販売元／メルクバイオファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤/チロシンキナーゼ阻害薬 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291065F1024 |
| Approval numbers | 30200AMX00435000 |
| Package insert edition | 第6版 |
| Package insert date | Jan 24, 2025 |
| PMDA document key | 380079_4291065F1024_1 |
| PMDA company code | 380079 |
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: