PMDA drug package insert
タバリス錠100mg
PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert May 29, 2026
Key facts
| Brand names | タバリス錠100mg, タバリス錠150mg |
|---|---|
| Nonproprietary names | ホスタマチニブナトリウム水和物 |
| Companies | 製造販売元／キッセイ薬品工業株式会社, 提携先／Rigel Pharmaceuticals, Inc. |
| Product type | Prescription drug |
| Therapeutic category | 経口血小板破壊抑制薬／脾臓チロシンキナーゼ阻害薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999058F1026, 3999058F2022 |
| Approval numbers | 30400AMX00459000, 30400AMX00460000 |
| Package insert edition | 第5版 |
| Package insert date | May 29, 2026 |
| PMDA document key | 230034_3999058F1026_1 |
| PMDA company code | 230034 |
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: