PMDA drug package insert
オフェブカプセル100mg
PMDA Prescription drug · 日本ベーリンガーインゲルハイム株式会社 · package insert May 18, 2026
Key facts
| Brand names | オフェブカプセル100mg, オフェブカプセル150mg |
|---|---|
| Nonproprietary names | ニンテダニブエタンスルホン酸塩 |
| 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 | チロシンキナーゼ阻害剤; 抗線維化剤 |
| Therapeutic category codes | 87399 |
| YJ codes | 3999039M1022, 3999039M2029 |
| Approval numbers | 22700AMX00693000, 22700AMX00694000 |
| Package insert edition | 第8版 |
| Package insert date | May 18, 2026 |
| PMDA document key | 650168_3999039M1022_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: